{
  "dataset": {
    "name": "Compounding Regulatory Tracker",
    "url": "https://nphla.com/trackers/compounding-regulatory-tracker",
    "description": "Official federal records on drug compounding — Federal Register rules, proposed rules and notices, FDA announcements and safety alerts, and FDA enforcement-report recalls — tagged to 503A, 503B, GLP-1 compounding, USP standards, peptides and enforcement.",
    "publisher": "National Pharmacy Health & Leadership Alliance",
    "howToCite": "National Pharmacy Health & Leadership Alliance (NPHLA). nphla.com. “Compounding Regulatory Tracker.” Updated Nov 13, 2026. https://nphla.com/trackers/compounding-regulatory-tracker. Accessed November 15, 2026.",
    "kind": "Compounding regulatory tracker (Federal Register / FDA)",
    "dataOrigin": "NPHLA analysis of public data",
    "jurisdiction": "United States (federal)",
    "methodology": "The Intelligence pipeline collects official records from the Federal Register API (including a dedicated FDA compounding search), FDA press announcements, MedWatch safety alerts and recall feeds, and openFDA enforcement reports (including a search for recalls of compounded drugs). Each record is classified against the knowledge graph by matching topic names and keywords in its title and summary.\n\nThis tracker lists records from primary sources tagged with a compounding topic. News and trade-press items are excluded.",
    "coverage": "U.S. federal records (FDA and the Federal Register) published since tracking of each source began. State board actions and documents FDA publishes only on its website, such as warning letters, are not yet included.",
    "limitations": "Classification is automatic and keyword-based: a record can be missed if it does not use the tracked terms, and a record can occasionally be tagged to a topic it mentions only in passing. Recall records name the firms involved exactly as FDA publishes them. Not legal advice — read the official document.",
    "updateFrequency": "Sources are checked every 1 to 6 hours depending on the source, as configured in the Source Registry.",
    "selection": "Official records (final rule, proposed rule, notice, recall, press release and safety alert) from primary sources tagged “503a”, “503b”, “glp1-compounding”, “usp-compounding”, “peptides” and “compounding-enforcement” in the NPHLA knowledge graph.",
    "systemCheckedAt": "2026-11-15T20:05:04.205Z",
    "editoriallyReviewedAt": null,
    "editorialReview": "pending",
    "generatedAt": "2026-11-15T20:57:46.949Z",
    "recordCount": 98,
    "notAdvice": "Professional information compiled from public sources. Not medical, legal or regulatory advice; always confirm in the primary source."
  },
  "columns": [
    {
      "key": "recordType",
      "label": "Record type"
    }
  ],
  "records": [
    {
      "key": "item:3173",
      "record": "Medline Updates Customers and Patients on Repair and Replace Program for Recall of Medline Brand Beds, Rails, Mattresses and Accessories",
      "subtitle": null,
      "detail": "On October 14, 2026, Medline initiated a product recall, market exit and discontinuation of all Medline Brand beds, rails, mattresses, and accessories (e.g., pendants and motor boxes) due to a potential fire hazard and entrapment risk, whi…",
      "status": "Recall",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration",
        "classification": null,
        "firm": null,
        "recallNumber": null
      },
      "jurisdiction": "US",
      "date": "2026-11-13T19:23:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Medline Updates Customers and Patients on Repair and Replace Program for Recall of Medline Brand Beds, Rails, Mattresses and Accessories",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medline-updates-customers-and-patients-repair-and-replace-program-recall-medline-brand-beds-rails",
        "publisher": "U.S. Food and Drug Administration",
        "type": "Official record"
      },
      "lastChecked": "2026-11-13T21:05:01.546Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-11-13T21:05:01.944Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-11-13T19:23:00.000Z",
        "withinLast7Days": true
      },
      "origin": "automated"
    },
    {
      "key": "item:3096",
      "record": "Eros Apothecary Issues Recall of Candy Power For Man Organic Honey Due to Undeclared Tadalafil",
      "subtitle": null,
      "detail": "Eros Apothecary of Indio, California is recalling Candy Power For Man Organic Honey because the product was found to contain undeclared tadalafil.",
      "status": "Recall",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration",
        "classification": null,
        "firm": null,
        "recallNumber": null
      },
      "jurisdiction": "US",
      "date": "2026-11-12T16:25:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Eros Apothecary Issues Recall of Candy Power For Man Organic Honey Due to Undeclared Tadalafil",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/eros-apothecary-issues-recall-candy-power-man-organic-honey-due-undeclared-tadalafil",
        "publisher": "U.S. Food and Drug Administration",
        "type": "Official record"
      },
      "lastChecked": "2026-11-12T18:35:01.640Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-11-12T18:35:02.221Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-11-12T16:25:00.000Z",
        "withinLast7Days": true
      },
      "origin": "automated"
    },
    {
      "key": "item:3095",
      "record": "Game Changer Products LLC Issues Voluntary Nationwide Recall of 10 Day Forecast Capsules Due to the Presence of Undeclared Sildenafil and Acetaminophen",
      "subtitle": null,
      "detail": "FOR IMMEDIATE RELEASE – November 12, 2026 - Tampa, Florida. Game Changer Products LLC is voluntarily recalling all lots of 10 Day Forecast capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil and…",
      "status": "Safety alert",
      "fields": {
        "recordType": "Safety alert",
        "publisher": "U.S. Food and Drug Administration (MedWatch)"
      },
      "jurisdiction": "US",
      "date": "2026-11-12T05:00:00.000Z",
      "dateType": "Published",
      "source": {
        "title": "Game Changer Products LLC Issues Voluntary Nationwide Recall of 10 Day Forecast Capsules Due to the Presence of Undeclared Sildenafil and Acetaminophen",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/game-changer-products-llc-issues-voluntary-nationwide-recall-10-day-forecast-capsules-due-presence",
        "publisher": "U.S. Food and Drug Administration (MedWatch)",
        "type": "Official record"
      },
      "lastChecked": "2026-11-12T18:35:01.492Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-11-12T18:35:01.952Z",
      "change": {
        "note": "Safety alert published",
        "at": "2026-11-12T05:00:00.000Z",
        "withinLast7Days": true
      },
      "origin": "automated"
    },
    {
      "key": "item:2970",
      "record": "Family Farmstead Dairy Announces Recall of All Cheddar Cheese Products Because of Possible Health Risk",
      "subtitle": null,
      "detail": "Worcester, New York – Family Farmstead Dairy is recalling all cheddar cheese products because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young…",
      "status": "Recall",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration",
        "classification": null,
        "firm": null,
        "recallNumber": null
      },
      "jurisdiction": "US",
      "date": "2026-11-10T05:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Family Farmstead Dairy Announces Recall of All Cheddar Cheese Products Because of Possible Health Risk",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/family-farmstead-dairy-announces-recall-all-cheddar-cheese-products-because-possible-health-risk",
        "publisher": "U.S. Food and Drug Administration",
        "type": "Official record"
      },
      "lastChecked": "2026-11-11T00:35:03.139Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-11-11T00:35:03.570Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-11-10T05:00:00.000Z",
        "withinLast7Days": true
      },
      "origin": "automated"
    },
    {
      "key": "item:2833",
      "record": "MedWatch Alert: FDA Requires Safety Labeling Changes for Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) Due to Potential Increased Risk of Rare But Serious Eye Condition: FDA Safety Communication",
      "subtitle": null,
      "detail": "FDA Requires Safety Labeling Changes for Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) Due to Potential Increased Risk of Rare But Serious Eye Condition: FDA Safety Communication",
      "status": "Safety alert",
      "fields": {
        "recordType": "Safety alert",
        "publisher": "U.S. Food and Drug Administration (MedWatch)"
      },
      "jurisdiction": "US",
      "date": "2026-11-09T05:00:00.000Z",
      "dateType": "Published",
      "source": {
        "title": "MedWatch Alert: FDA Requires Safety Labeling Changes for Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) Due to Potential Increased Risk of Rare But Serious Eye Condition: FDA Safety Communication",
        "url": "https://www.fda.gov/safety/medical-product-safety-information/medwatch-alert-fda-requires-safety-labeling-changes-glucagon-peptide-1-receptor-agonists-glp-1-ras",
        "publisher": "U.S. Food and Drug Administration (MedWatch)",
        "type": "Official record"
      },
      "lastChecked": "2026-11-09T19:05:04.830Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-11-09T19:05:05.785Z",
      "change": {
        "note": "Safety alert published",
        "at": "2026-11-09T05:00:00.000Z",
        "withinLast7Days": true
      },
      "origin": "automated"
    },
    {
      "key": "item:2832",
      "record": "Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers (AIC)",
      "subtitle": null,
      "detail": "Abiomed is removing certain Impella Controllers with various hardware, firmware, and/or software updates based on a retrospective review of servicing records.",
      "status": "Safety alert",
      "fields": {
        "recordType": "Safety alert",
        "publisher": "U.S. Food and Drug Administration (MedWatch)"
      },
      "jurisdiction": "US",
      "date": "2026-11-09T05:00:00.000Z",
      "dateType": "Published",
      "source": {
        "title": "Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers (AIC)",
        "url": "https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/heart-pump-controller-recall-abiomed-removes-automated-impella-controllers-aic",
        "publisher": "U.S. Food and Drug Administration (MedWatch)",
        "type": "Official record"
      },
      "lastChecked": "2026-11-09T19:05:04.830Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-11-09T19:05:06.032Z",
      "change": {
        "note": "Safety alert published",
        "at": "2026-11-09T05:00:00.000Z",
        "withinLast7Days": true
      },
      "origin": "automated"
    },
    {
      "key": "item:2827",
      "record": "Eugia US LLC (f/k/a Auro Medics Pharma LLC) Issues Voluntary Nationwide Recall of Vancomycin Hydrochloride for Injection USP 1.25g/Vial-30mL (Single Dose Vial) Due to Presence of Particulate Matter",
      "subtitle": null,
      "detail": "FOR IMMEDIATE RELEASE –November 06,2026 – East Windsor, New Jersey, Eugia US LLC (f/k/a Auro Medics Pharma LLC) is voluntarily recalling lot number 3VM26026A of Vancomycin Hydrochloride for Injection USP 1.25g/Vial-30mL (Single Dose Vial)…",
      "status": "Recall",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration",
        "classification": null,
        "firm": null,
        "recallNumber": null
      },
      "jurisdiction": "US",
      "date": "2026-11-06T05:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Eugia US LLC (f/k/a Auro Medics Pharma LLC) Issues Voluntary Nationwide Recall of Vancomycin Hydrochloride for Injection USP 1.25g/Vial-30mL (Single Dose Vial) Due to Presence of Particulate Matter",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/eugia-us-llc-fka-auro-medics-pharma-llc-issues-voluntary-nationwide-recall-vancomycin-hydrochloride",
        "publisher": "U.S. Food and Drug Administration",
        "type": "Official record"
      },
      "lastChecked": "2026-11-09T17:35:01.745Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-11-09T17:35:02.235Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-11-06T05:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:2323",
      "record": "Platelet Factor 4 (PF4) Radioimmunoassay Recall: Instrumentation Laboratories Removes HemosIL AcuStar HIT-IgG(PF4-H)",
      "subtitle": null,
      "detail": "Product performance issue may lead to a false negative result which will delay recognition of heparin-induced thrombocytopenia.",
      "status": "Safety alert",
      "fields": {
        "recordType": "Safety alert",
        "publisher": "U.S. Food and Drug Administration (MedWatch)"
      },
      "jurisdiction": "US",
      "date": "2026-10-30T04:00:00.000Z",
      "dateType": "Published",
      "source": {
        "title": "Platelet Factor 4 (PF4) Radioimmunoassay Recall: Instrumentation Laboratories Removes HemosIL AcuStar HIT-IgG(PF4-H)",
        "url": "https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/platelet-factor-4-pf4-radioimmunoassay-recall-instrumentation-laboratories-removes-hemosil-acustar",
        "publisher": "U.S. Food and Drug Administration (MedWatch)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-30T19:35:44.201Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-30T19:35:55.026Z",
      "change": {
        "note": "Safety alert published",
        "at": "2026-10-30T04:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:2100",
      "record": "Taylor Farms Issues Recall for H-E-B Backyard BBQ Chop Salad Kit Due to the Potential Undeclared Soy and Tree Nuts(Almonds)",
      "subtitle": null,
      "detail": "Taylor Farms of Dallas, Texas is recalling H-E-B Backyard BBQ Chop Salad kit due to the potential undeclared soy and tree nuts(almonds).",
      "status": "Recall",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration",
        "classification": null,
        "firm": null,
        "recallNumber": null
      },
      "jurisdiction": "US",
      "date": "2026-10-27T18:18:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Taylor Farms Issues Recall for H-E-B Backyard BBQ Chop Salad Kit Due to the Potential Undeclared Soy and Tree Nuts(Almonds)",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/taylor-farms-issues-recall-h-e-b-backyard-bbq-chop-salad-kit-due-potential-undeclared-soy-and-tree",
        "publisher": "U.S. Food and Drug Administration",
        "type": "Official record"
      },
      "lastChecked": "2026-10-27T19:35:02.965Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-27T19:35:03.840Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-10-27T18:18:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:1931",
      "record": "Tonight We Ride, LLC Issues Voluntary Recall of Ultimate Forza Male Supplement Due to Presence of Undeclared Sildenafil, Tadalafil, and Dapoxetine",
      "subtitle": null,
      "detail": "October 24, 2026, Tonight We Ride, LLC of Lakeville, Minnesota is voluntarily recalling all lots of Ultimate Forza Male Supplement capsules to the consumer level because it has been found to contain undeclared Sildenafil, Tadalafil, and Da…",
      "status": "Recall",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration",
        "classification": null,
        "firm": null,
        "recallNumber": null
      },
      "jurisdiction": "US",
      "date": "2026-10-24T18:23:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Tonight We Ride, LLC Issues Voluntary Recall of Ultimate Forza Male Supplement Due to Presence of Undeclared Sildenafil, Tadalafil, and Dapoxetine",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tonight-we-ride-llc-issues-voluntary-recall-ultimate-forza-male-supplement-due-presence-undeclared",
        "publisher": "U.S. Food and Drug Administration",
        "type": "Official record"
      },
      "lastChecked": "2026-10-24T21:35:02.286Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-24T21:35:03.116Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-10-24T18:23:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:1721",
      "record": "Wedgewood Pharmacy Issues Recall of Certain Compounded Veterinary Medications Within Expiry Due to Potential Potency Issues",
      "subtitle": null,
      "detail": "SWEDESBORO, N.J., (October 21, 2026) - Wedgewood Pharmacy LLC (\"Wedgewood\") is recalling certain compounded veterinary medications within expiry at the provider/customer level due to inconsistencies in the reliability of certain analytical…",
      "status": "Safety alert",
      "fields": {
        "recordType": "Safety alert",
        "publisher": "U.S. Food and Drug Administration (MedWatch)"
      },
      "jurisdiction": "US",
      "date": "2026-10-21T04:00:00.000Z",
      "dateType": "Published",
      "source": {
        "title": "Wedgewood Pharmacy Issues Recall of Certain Compounded Veterinary Medications Within Expiry Due to Potential Potency Issues",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wedgewood-pharmacy-issues-recall-certain-compounded-veterinary-medications-within-expiry-due",
        "publisher": "U.S. Food and Drug Administration (MedWatch)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-21T21:35:01.921Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-21T21:35:02.257Z",
      "change": {
        "note": "Safety alert published",
        "at": "2026-10-21T04:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:2034",
      "record": "Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.",
      "subtitle": "Recall D-0040-2027",
      "detail": "Reason: Lack of assurance of sterility.",
      "status": "Class II · Ongoing",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "Houston Rx LLC",
        "recallNumber": "D-0040-2027"
      },
      "jurisdiction": "US",
      "date": "2026-10-21T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage…",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0040-2027%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-26T23:35:02.654Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-26T23:35:04.083Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-10-21T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:1761",
      "record": "Update: Import Alert for Certain Olympus Medical Devices Manufactured in Japan - Letter to Health Care Providers",
      "subtitle": null,
      "detail": "The U.S. Food and Drug Administration (FDA) is alerting health care providers about import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus) and its subsidiaries.",
      "status": "Safety alert",
      "fields": {
        "recordType": "Safety alert",
        "publisher": "U.S. Food and Drug Administration (MedWatch)"
      },
      "jurisdiction": "US",
      "date": "2026-10-20T04:00:00.000Z",
      "dateType": "Published",
      "source": {
        "title": "Update: Import Alert for Certain Olympus Medical Devices Manufactured in Japan - Letter to Health Care Providers",
        "url": "https://www.fda.gov/medical-devices/letters-health-care-providers/update-import-alert-certain-olympus-medical-devices-manufactured-japan-letter-health-care-providers",
        "publisher": "U.S. Food and Drug Administration (MedWatch)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-22T16:05:04.997Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-22T16:05:05.956Z",
      "change": {
        "note": "Safety alert published",
        "at": "2026-10-20T04:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:1635",
      "record": "Import Alert for Certain Olympus Medical Devices Manufactured in Japan - Letter to Health Care Providers",
      "subtitle": null,
      "detail": "The U.S. Food and Drug Administration (FDA) is alerting health care providers about import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus) and its subsidiaries.",
      "status": "Safety alert",
      "fields": {
        "recordType": "Safety alert",
        "publisher": "U.S. Food and Drug Administration (MedWatch)"
      },
      "jurisdiction": "US",
      "date": "2026-10-20T04:00:00.000Z",
      "dateType": "Published",
      "source": {
        "title": "Import Alert for Certain Olympus Medical Devices Manufactured in Japan - Letter to Health Care Providers",
        "url": "https://www.fda.gov/medical-devices/letters-health-care-providers/import-alert-certain-olympus-medical-devices-manufactured-japan-letter-health-care-providers",
        "publisher": "U.S. Food and Drug Administration (MedWatch)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-20T20:35:03.527Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-20T20:35:04.936Z",
      "change": {
        "note": "Safety alert published",
        "at": "2026-10-20T04:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:1469",
      "record": "Family Farmstead Dairy Announces Recall of Raw Mild Cheddar Cheese Due to Potential E. coli O26:H11 and O45:H2 Contamination",
      "subtitle": null,
      "detail": "WORCESTER, NY, October 15, 2026 - Family Farmstead Dairy of Worcester, NY is recalling specific lot of cheddar cheese because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). E. coli O157:H7 causes a diarrhe…",
      "status": "Recall",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration",
        "classification": null,
        "firm": null,
        "recallNumber": null
      },
      "jurisdiction": "US",
      "date": "2026-10-15T20:04:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Family Farmstead Dairy Announces Recall of Raw Mild Cheddar Cheese Due to Potential E. coli O26:H11 and O45:H2 Contamination",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/family-farmstead-dairy-announces-recall-raw-mild-cheddar-cheese-due-potential-e-coli-o26h11-and",
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      "origin": "automated"
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      "key": "item:1264",
      "record": "Par Health Issues Voluntary Nationwide Recall of Argatroban Injection Due to the Presence of Particulate Matter",
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      "origin": "automated"
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      "key": "item:1247",
      "record": "Convenience Kit Recall: AVID Medical Removes Convenience Kits Affected by BD ChloraPrep Applicator Recall",
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      "jurisdiction": "US",
      "date": "2026-10-14T04:00:00.000Z",
      "dateType": "Published",
      "source": {
        "title": "Convenience Kit Recall: AVID Medical Removes Convenience Kits Affected by BD ChloraPrep Applicator Recall",
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      "nphlaUpdatedAt": "2026-10-14T13:35:03.478Z",
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        "note": "Safety alert published",
        "at": "2026-10-14T04:00:00.000Z",
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      "detail": "Reason: Lack of Assurance of Sterility",
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        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
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        "recallNumber": "D-0036-2027"
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      "jurisdiction": "US",
      "date": "2026-10-14T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans…",
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      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-21T02:35:04.864Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-10-14T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
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      "subtitle": "Recall D-0018-2027",
      "detail": "Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.",
      "status": "Class II · Ongoing",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
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        "recallNumber": "D-0018-2027"
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      "jurisdiction": "US",
      "date": "2026-10-14T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland,…",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0018-2027%22",
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      "lastChecked": "2026-10-20T23:35:02.536Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-20T23:35:05.962Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-10-14T00:00:00.000Z",
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      "origin": "automated"
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      "record": "SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE,  Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription,…",
      "subtitle": "Recall D-0019-2027",
      "detail": "Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.",
      "status": "Class II · Ongoing",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "Carolina Infusion, LLC",
        "recallNumber": "D-0019-2027"
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      "jurisdiction": "US",
      "date": "2026-10-14T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE,  Packaged in single-use dosage syringes, total mL dispensed…",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0019-2027%22",
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        "type": "Official record"
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      "lastChecked": "2026-10-20T23:35:02.536Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-20T23:35:06.320Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-10-14T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
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    {
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      "record": "SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription,…",
      "subtitle": "Recall D-0026-2027",
      "detail": "Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.",
      "status": "Class II · Ongoing",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "Carolina Infusion, LLC",
        "recallNumber": "D-0026-2027"
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      "jurisdiction": "US",
      "date": "2026-10-14T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed…",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0026-2027%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
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      "lastChecked": "2026-10-20T23:35:02.536Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-20T23:35:06.677Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-10-14T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
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    {
      "key": "item:1654",
      "record": "TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusio…",
      "subtitle": "Recall D-0017-2027",
      "detail": "Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.",
      "status": "Class II · Ongoing",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "Carolina Infusion, LLC",
        "recallNumber": "D-0017-2027"
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      "jurisdiction": "US",
      "date": "2026-10-14T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage…",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0017-2027%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
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      "lastChecked": "2026-10-20T23:35:02.536Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-20T23:35:07.012Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-10-14T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
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    {
      "key": "item:1653",
      "record": "TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription,…",
      "subtitle": "Recall D-0029-2027",
      "detail": "Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.",
      "status": "Class II · Ongoing",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "Carolina Infusion, LLC",
        "recallNumber": "D-0029-2027"
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      "jurisdiction": "US",
      "date": "2026-10-14T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed…",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0029-2027%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
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      "lastChecked": "2026-10-20T23:35:02.536Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-20T23:35:07.348Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-10-14T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
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    {
      "key": "item:1652",
      "record": "TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription,…",
      "subtitle": "Recall D-0028-2027",
      "detail": "Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.",
      "status": "Class II · Ongoing",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "Carolina Infusion, LLC",
        "recallNumber": "D-0028-2027"
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      "jurisdiction": "US",
      "date": "2026-10-14T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed…",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0028-2027%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
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      "lastChecked": "2026-10-20T23:35:02.536Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-20T23:35:07.690Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-10-14T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
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    {
      "key": "item:1651",
      "record": "TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription,…",
      "subtitle": "Recall D-0030-2027",
      "detail": "Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.",
      "status": "Class II · Ongoing",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "Carolina Infusion, LLC",
        "recallNumber": "D-0030-2027"
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      "jurisdiction": "US",
      "date": "2026-10-14T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed…",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0030-2027%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
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      "lastChecked": "2026-10-20T23:35:02.536Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-20T23:35:08.022Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-10-14T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
    },
    {
      "key": "item:1650",
      "record": "Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription…",
      "subtitle": "Recall D-0031-2027",
      "detail": "Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.",
      "status": "Class II · Ongoing",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "Carolina Infusion, LLC",
        "recallNumber": "D-0031-2027"
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      "jurisdiction": "US",
      "date": "2026-10-14T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, Packaged in single-use dosage syringes, total mL…",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0031-2027%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
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      "lastChecked": "2026-10-20T23:35:02.536Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-20T23:35:08.434Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-10-14T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
    },
    {
      "key": "item:1649",
      "record": "Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescriptio…",
      "subtitle": "Recall D-0024-2027",
      "detail": "Reason: Lack of Assurance of Sterility:  Related to processing equipment used in compounded product.",
      "status": "Class II · Ongoing",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "Carolina Infusion, LLC",
        "recallNumber": "D-0024-2027"
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      "jurisdiction": "US",
      "date": "2026-10-14T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use dosage syringes, total mL…",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0024-2027%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
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      "lastChecked": "2026-10-20T23:35:02.536Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-20T23:35:08.775Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-10-14T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
    },
    {
      "key": "item:1648",
      "record": "Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina I…",
      "subtitle": "Recall D-0032-2027",
      "detail": "Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.",
      "status": "Class II · Ongoing",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "Carolina Infusion, LLC",
        "recallNumber": "D-0032-2027"
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      "jurisdiction": "US",
      "date": "2026-10-14T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on…",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0032-2027%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
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      "lastChecked": "2026-10-20T23:35:02.536Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-20T23:35:09.134Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-10-14T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
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    {
      "key": "item:1647",
      "record": "Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription…",
      "subtitle": "Recall D-0025-2027",
      "detail": "Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.",
      "status": "Class II · Ongoing",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "Carolina Infusion, LLC",
        "recallNumber": "D-0025-2027"
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      "jurisdiction": "US",
      "date": "2026-10-14T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes, total mL…",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0025-2027%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
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      "lastChecked": "2026-10-20T23:35:02.536Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-20T23:35:09.501Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-10-14T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
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    {
      "key": "item:1646",
      "record": "Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable,  Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescriptio…",
      "subtitle": "Recall D-0023-2027",
      "detail": "Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.",
      "status": "Class II · Ongoing",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "Carolina Infusion, LLC",
        "recallNumber": "D-0023-2027"
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      "jurisdiction": "US",
      "date": "2026-10-14T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable,  Packaged in single-use dosage syringes, total mL…",
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      "nphlaUpdatedAt": "2026-10-20T23:35:09.834Z",
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    {
      "key": "item:1645",
      "record": "Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable,  Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescriptio…",
      "subtitle": "Recall D-0022-2027",
      "detail": "Reason: Lack of Assurance of Sterility:  Related to processing equipment used in compounded product.",
      "status": "Class II · Ongoing",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
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        "firm": "Carolina Infusion, LLC",
        "recallNumber": "D-0022-2027"
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      "jurisdiction": "US",
      "date": "2026-10-14T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable,  Packaged in single-use dosage syringes, total mL…",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0022-2027%22",
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      "nphlaUpdatedAt": "2026-10-20T23:35:10.181Z",
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    {
      "key": "item:1644",
      "record": "TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription,…",
      "subtitle": "Recall D-0027-2027",
      "detail": "Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.",
      "status": "Class II · Ongoing",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
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        "firm": "Carolina Infusion, LLC",
        "recallNumber": "D-0027-2027"
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      "jurisdiction": "US",
      "date": "2026-10-14T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed…",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0027-2027%22",
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      "nphlaUpdatedAt": "2026-10-20T23:35:10.531Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-10-14T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
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    {
      "key": "item:1643",
      "record": "QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, C…",
      "subtitle": "Recall D-0021-2027",
      "detail": "Reason: Lack of Assurance of Sterility:   Related to processing equipment used in compounded product.",
      "status": "Class II · Ongoing",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "Carolina Infusion, LLC",
        "recallNumber": "D-0021-2027"
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      "jurisdiction": "US",
      "date": "2026-10-14T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed…",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0021-2027%22",
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      "nphlaUpdatedAt": "2026-10-20T23:35:10.964Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-10-14T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:1192",
      "record": "Convenience Kit Recall: Medline Removes Convenience Kits Affected by BD ChloraPrep Applicator Recall",
      "subtitle": null,
      "detail": "Certain Medline convenience kits containing recalled BD ChloraPrep applicators should be removed from use due to potential fungal contamination",
      "status": "Safety alert",
      "fields": {
        "recordType": "Safety alert",
        "publisher": "U.S. Food and Drug Administration (MedWatch)"
      },
      "jurisdiction": "US",
      "date": "2026-10-13T04:00:00.000Z",
      "dateType": "Published",
      "source": {
        "title": "Convenience Kit Recall: Medline Removes Convenience Kits Affected by BD ChloraPrep Applicator Recall",
        "url": "https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/convenience-kit-recall-medline-removes-convenience-kits-affected-bd-chloraprep-applicator-recall",
        "publisher": "U.S. Food and Drug Administration (MedWatch)",
        "type": "Official record"
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      "lastChecked": "2026-10-13T17:35:02.007Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-13T17:35:03.135Z",
      "change": {
        "note": "Safety alert published",
        "at": "2026-10-13T04:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:1017",
      "record": "Par Health Issues Voluntary Nationwide Recall of Two Lots of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) Due to the Presence of Particulate Matter",
      "subtitle": null,
      "detail": "FOR IMMEDIATE RELEASE - ROCHESTER, MI– October 8, 2026 –Par Health is voluntarily recalling two lots of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) to the hospital level. The product is being recalled due to t…",
      "status": "Safety alert",
      "fields": {
        "recordType": "Safety alert",
        "publisher": "U.S. Food and Drug Administration (MedWatch)"
      },
      "jurisdiction": "US",
      "date": "2026-10-09T04:00:00.000Z",
      "dateType": "Published",
      "source": {
        "title": "Par Health Issues Voluntary Nationwide Recall of Two Lots of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) Due to the Presence of Particulate Matter",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/par-health-issues-voluntary-nationwide-recall-two-lots-brevitalr-sodium-500-mgvial-civ-methohexital",
        "publisher": "U.S. Food and Drug Administration (MedWatch)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-09T17:05:01.440Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-09T17:05:02.502Z",
      "change": {
        "note": "Safety alert published",
        "at": "2026-10-09T04:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:837",
      "record": "Leader Formulas, LLC. Issues Voluntary Nationwide Recall of RAPTURE Preworkout Due to the Presence of 1,3-Dimethylamylamine (DMAA)",
      "subtitle": null,
      "detail": "Leader Formulas, LLC. of Tomball, TX, is voluntarily recalling one (1) lot of RAPTURE Pre workout, a dietary supplement powder because it was found to contain 1,3-Dimethylamylamine (DMAA) and sold at the consumer level. Using DMAA can resu…",
      "status": "Recall",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration",
        "classification": null,
        "firm": null,
        "recallNumber": null
      },
      "jurisdiction": "US",
      "date": "2026-10-06T13:30:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Leader Formulas, LLC. Issues Voluntary Nationwide Recall of RAPTURE Preworkout Due to the Presence of 1,3-Dimethylamylamine (DMAA)",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/leader-formulas-llc-issues-voluntary-nationwide-recall-rapture-preworkout-due-presence-13",
        "publisher": "U.S. Food and Drug Administration",
        "type": "Official record"
      },
      "lastChecked": "2026-10-07T15:05:01.575Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-07T15:05:01.786Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-10-06T13:30:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:709",
      "record": "Infusion Set Recall: BD and CareFusion 303, Inc. Remove BD Alaris Pump Infusion Sets",
      "subtitle": null,
      "detail": "BD Alaris Pump Infusion Sets are being removed and discontinued; Alaris Pump Module model 8100 has updated performance data",
      "status": "Safety alert",
      "fields": {
        "recordType": "Safety alert",
        "publisher": "U.S. Food and Drug Administration (MedWatch)"
      },
      "jurisdiction": "US",
      "date": "2026-10-05T04:00:00.000Z",
      "dateType": "Published",
      "source": {
        "title": "Infusion Set Recall: BD and CareFusion 303, Inc. Remove BD Alaris Pump Infusion Sets",
        "url": "https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/infusion-set-recall-bd-and-carefusion-303-inc-remove-bd-alaris-pump-infusion-sets",
        "publisher": "U.S. Food and Drug Administration (MedWatch)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-05T20:05:02.838Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-05T20:05:04.365Z",
      "change": {
        "note": "Safety alert published",
        "at": "2026-10-05T04:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:585",
      "record": "Frutas y Hortalizas del Sur S.A. Expands Recalls to Include Additional Lots of Great Value Frozen Organic Triple Berry Blend 10 OZ, Great Value Frozen Organic Blueberries 10 OZ and One Lot of Trader Joe’s Frozen Organic Mixed Berry Blend 12 OZ Because of Potential Contamination with E. coli O145",
      "subtitle": null,
      "detail": "October 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its previously initiated recalls on July 3, 2026 and September 3,2026 recall of frozen organic IQF blueberries and berry blends to include additional lots of Gre…",
      "status": "Recall",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration",
        "classification": null,
        "firm": null,
        "recallNumber": null
      },
      "jurisdiction": "US",
      "date": "2026-10-02T19:06:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Frutas y Hortalizas del Sur S.A. Expands Recalls to Include Additional Lots of Great Value Frozen Organic Triple Berry Blend 10 OZ, Great Value Frozen Organic Blueberries 10 OZ and One Lot of Trader Joe’s Frozen Organic Mixed Berry Blend 12 OZ Because of Potential Contamination with E. coli O145",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/frutas-y-hortalizas-del-sur-sa-expands-recalls-include-additional-lots-great-value-frozen-organic",
        "publisher": "U.S. Food and Drug Administration",
        "type": "Official record"
      },
      "lastChecked": "2026-10-02T21:05:02.306Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-02T21:05:03.457Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-10-02T19:06:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:692",
      "record": "Flowers Foods Issues Recall of Nature’s Own Hawaiian Bread Due to Undeclared Milk",
      "subtitle": null,
      "detail": "THOMASVILLE, GA., October 2, 2026 – Flowers Foods, Inc. (NYSE: FLO) is recalling Nature’s Own® Hawaiian Bread, 20 oz. and 40 oz. bags, due to undeclared milk. People who have an allergy or severe sensitivity to milk may run the risk of an…",
      "status": "Recall",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration",
        "classification": null,
        "firm": null,
        "recallNumber": null
      },
      "jurisdiction": "US",
      "date": "2026-10-02T16:31:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Flowers Foods Issues Recall of Nature’s Own Hawaiian Bread Due to Undeclared Milk",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/flowers-foods-issues-recall-natures-own-hawaiian-bread-due-undeclared-milk",
        "publisher": "U.S. Food and Drug Administration",
        "type": "Official record"
      },
      "lastChecked": "2026-10-05T18:35:01.938Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-05T18:35:02.478Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-10-02T16:31:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:586",
      "record": "Breathing Circuit Recall: Draeger Removes VentStar Resus Neo Hoses",
      "subtitle": null,
      "detail": "Removal of VentStar Resus Neo hoses due to the potential for cracks resulting in restricted ventilation or delayed therapy.",
      "status": "Safety alert",
      "fields": {
        "recordType": "Safety alert",
        "publisher": "U.S. Food and Drug Administration (MedWatch)"
      },
      "jurisdiction": "US",
      "date": "2026-10-02T04:00:00.000Z",
      "dateType": "Published",
      "source": {
        "title": "Breathing Circuit Recall: Draeger Removes VentStar Resus Neo Hoses",
        "url": "https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/breathing-circuit-recall-draeger-removes-ventstar-resus-neo-hoses",
        "publisher": "U.S. Food and Drug Administration (MedWatch)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-02T21:05:02.533Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-02T21:05:03.706Z",
      "change": {
        "note": "Safety alert published",
        "at": "2026-10-02T04:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:624",
      "record": "Saint Francis Apizza LLC Issues a Voluntary Recall of its Frozen Pizzas for Missing Sub Ingredients on the Label for Soy Which Includes Soybean Oil and Soy Lecithin, an Allergen",
      "subtitle": null,
      "detail": "Cincinnati, Ohio October 1, 2026. Saint Francis Apizza LLC is issuing a voluntary recall on their frozen pizzas for misbranding due to the soy allergen not being declared on the label. The frozen pizzas were sold in ‘Pepperoni,’ ‘Plain Che…",
      "status": "Recall",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration",
        "classification": null,
        "firm": null,
        "recallNumber": null
      },
      "jurisdiction": "US",
      "date": "2026-10-01T04:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Saint Francis Apizza LLC Issues a Voluntary Recall of its Frozen Pizzas for Missing Sub Ingredients on the Label for Soy Which Includes Soybean Oil and Soy Lecithin, an Allergen",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/saint-francis-apizza-llc-issues-voluntary-recall-its-frozen-pizzas-missing-sub-ingredients-label-soy",
        "publisher": "U.S. Food and Drug Administration",
        "type": "Official record"
      },
      "lastChecked": "2026-10-03T19:35:03.814Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-03T19:35:05.718Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-10-01T04:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:516",
      "record": "Greenwich Rx Issues Voluntary Nationwide Recall of Compounded Glutathione Due to Elevated Endotoxin Levels",
      "subtitle": null,
      "detail": "IMMEDIATE RELEASE - Tomball, Texas – October 1, 2026 – Greenwich Rx, a 503A compounding pharmacy, is voluntarily recalling specific lots of its compounded glutathione to the consumer level. The product is being recalled due to potential el…",
      "status": "Safety alert",
      "fields": {
        "recordType": "Safety alert",
        "publisher": "U.S. Food and Drug Administration (MedWatch)"
      },
      "jurisdiction": "US",
      "date": "2026-10-01T04:00:00.000Z",
      "dateType": "Published",
      "source": {
        "title": "Greenwich Rx Issues Voluntary Nationwide Recall of Compounded Glutathione Due to Elevated Endotoxin Levels",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/greenwich-rx-issues-voluntary-nationwide-recall-compounded-glutathione-due-elevated-endotoxin-levels",
        "publisher": "U.S. Food and Drug Administration (MedWatch)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T23:35:01.798Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T23:35:02.643Z",
      "change": {
        "note": "Safety alert published",
        "at": "2026-10-01T04:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:2",
      "record": "G. L. Mezzetta Inc. Announces Recall of Mezzetta Brand Golden Greek Peperoncini (Medium Heat) Due to Presence of Pest Contaminant in the Jar",
      "subtitle": null,
      "detail": "For generations, families have trusted Mezzetta products on their tables. We take that trust seriously, which is why we want to share what we know about a voluntary recall involving a specific lot of Mezzetta GOLDEN GREEK PEPERONCINI MEDIU…",
      "status": "Recall",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration",
        "classification": null,
        "firm": null,
        "recallNumber": null
      },
      "jurisdiction": "US",
      "date": "2026-09-26T22:17:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "G. L. Mezzetta Inc. Announces Recall of Mezzetta Brand Golden Greek Peperoncini (Medium Heat) Due to Presence of Pest Contaminant in the Jar",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/g-l-mezzetta-inc-announces-recall-mezzetta-brand-golden-greek-peperoncini-medium-heat-due-presence",
        "publisher": "U.S. Food and Drug Administration",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:08.752Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:22.782Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-09-26T22:17:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:21",
      "record": "Angiographic Catheter Recall: Boston Scientific Removes Imager II Angiographic Catheters",
      "subtitle": null,
      "detail": "Boston Scientific Imager II Angiographic Catheters removed due to a manufacturing issue leading to tip detachment; could result in procedural delays, embolism",
      "status": "Safety alert",
      "fields": {
        "recordType": "Safety alert",
        "publisher": "U.S. Food and Drug Administration (MedWatch)"
      },
      "jurisdiction": "US",
      "date": "2026-09-25T04:00:00.000Z",
      "dateType": "Published",
      "source": {
        "title": "Angiographic Catheter Recall: Boston Scientific Removes Imager II Angiographic Catheters",
        "url": "https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/angiographic-catheter-recall-boston-scientific-removes-imager-ii-angiographic-catheters",
        "publisher": "U.S. Food and Drug Administration (MedWatch)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:09.176Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:24.060Z",
      "change": {
        "note": "Safety alert published",
        "at": "2026-09-25T04:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:22",
      "record": "Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers",
      "subtitle": null,
      "detail": "Abiomed is removing Automated Impella Controllers due to purge cassette recognition failures that may lead to prolonged delayed in mechanical circulatory support.",
      "status": "Safety alert",
      "fields": {
        "recordType": "Safety alert",
        "publisher": "U.S. Food and Drug Administration (MedWatch)"
      },
      "jurisdiction": "US",
      "date": "2026-09-24T04:00:00.000Z",
      "dateType": "Published",
      "source": {
        "title": "Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers",
        "url": "https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/heart-pump-controller-recall-abiomed-removes-automated-impella-controllers",
        "publisher": "U.S. Food and Drug Administration (MedWatch)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:09.176Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:23.910Z",
      "change": {
        "note": "Safety alert published",
        "at": "2026-09-24T04:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:41",
      "record": "Federal Court Enters Consent Decree Against Gold Star Distribution, Inc. Following Persistent Insanitary Warehouse Conditions",
      "subtitle": null,
      "detail": "A U.S. Food and Drug Administration investigation resulted in a federal court order, dated Sept. 21, 2026, stopping a warehouse operator from distributing FDA-regulated products including food, drugs, medical devices, and cosmetics until i…",
      "status": "Press release",
      "fields": {
        "recordType": "Press release",
        "publisher": "U.S. Food and Drug Administration"
      },
      "jurisdiction": "US",
      "date": "2026-09-23T19:50:17.000Z",
      "dateType": "Published",
      "source": {
        "title": "Federal Court Enters Consent Decree Against Gold Star Distribution, Inc. Following Persistent Insanitary Warehouse Conditions",
        "url": "https://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-gold-star-distribution-inc-following-persistent",
        "publisher": "U.S. Food and Drug Administration",
        "type": "Primary source"
      },
      "lastChecked": "2026-10-01T09:05:09.466Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:24.667Z",
      "change": {
        "note": "Press release published",
        "at": "2026-09-23T19:50:17.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:27",
      "record": "Ventilator Recall: CooperSurgical Removes INCA Infant Nasal CPAP Sets",
      "subtitle": null,
      "detail": "The cannula sets may exhibit a loose connection between the flexible tubing and the nasal cannula resulting in reduced effectiveness and decreased oxygenation.",
      "status": "Safety alert",
      "fields": {
        "recordType": "Safety alert",
        "publisher": "U.S. Food and Drug Administration (MedWatch)"
      },
      "jurisdiction": "US",
      "date": "2026-09-21T04:00:00.000Z",
      "dateType": "Published",
      "source": {
        "title": "Ventilator Recall: CooperSurgical Removes INCA Infant Nasal CPAP Sets",
        "url": "https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/ventilator-recall-coopersurgical-removes-inca-infant-nasal-cpap-sets",
        "publisher": "U.S. Food and Drug Administration (MedWatch)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:09.176Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:23.651Z",
      "change": {
        "note": "Safety alert published",
        "at": "2026-09-21T04:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:8",
      "record": "Par Health Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection Due to the Presence of Particulate Matter",
      "subtitle": null,
      "detail": "ROCHESTER, MI– September 18, 2026 –Par Health is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) to the hospital level. The product is being recalled due to the presence of…",
      "status": "Recall",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration",
        "classification": null,
        "firm": null,
        "recallNumber": null
      },
      "jurisdiction": "US",
      "date": "2026-09-18T19:14:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Par Health Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection Due to the Presence of Particulate Matter",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/par-health-issues-voluntary-nationwide-recall-two-lots-dexmedetomidine-hcl-09-sodium-chloride",
        "publisher": "U.S. Food and Drug Administration",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:08.752Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:22.515Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-09-18T19:14:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:28",
      "record": "Sodium Chloride Flush Recall: Spectra Medical Removes Sodium Chloride Injection USP Ampules",
      "subtitle": null,
      "detail": "Spectra Medical Devices is removing Sodium Chloride Flush products that were manufactured by Huons Co,. Ltd.",
      "status": "Safety alert",
      "fields": {
        "recordType": "Safety alert",
        "publisher": "U.S. Food and Drug Administration (MedWatch)"
      },
      "jurisdiction": "US",
      "date": "2026-09-18T04:00:00.000Z",
      "dateType": "Published",
      "source": {
        "title": "Sodium Chloride Flush Recall: Spectra Medical Removes Sodium Chloride Injection USP Ampules",
        "url": "https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/sodium-chloride-flush-recall-spectra-medical-removes-sodium-chloride-injection-usp-ampules",
        "publisher": "U.S. Food and Drug Administration (MedWatch)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:09.176Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:23.463Z",
      "change": {
        "note": "Safety alert published",
        "at": "2026-09-18T04:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:9",
      "record": "Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection, USP Due To a Product Mix-up with 10 mEq Potassium Chloride Injection",
      "subtitle": null,
      "detail": "Otsuka ICU Medical LLC is issuing a voluntary recall for one lot of 0.9% SODIUM CHLORIDE Injection, USP, 100mL single pack to the user level due to a potential mix-up. The affected lot of 0.9% SODIUM CHLORIDE Injection, USP (NDC: 0990-7984…",
      "status": "Recall",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration",
        "classification": null,
        "firm": null,
        "recallNumber": null
      },
      "jurisdiction": "US",
      "date": "2026-09-17T04:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection, USP Due To a Product Mix-up with 10 mEq Potassium Chloride Injection",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/otsuka-icu-medical-llc-issues-voluntary-nationwide-recall-09-sodium-chloride-injection-usp-due",
        "publisher": "U.S. Food and Drug Administration",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:08.752Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:22.366Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-09-17T04:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:11",
      "record": "So Delicious Dairy Free® Issues Voluntary Recall of Salted Caramel Cluster Non-Dairy Frozen Dessert Pints Due to Potential Presence of Foreign Material",
      "subtitle": null,
      "detail": "WHITE PLAINS, N.Y. and LOUISVILLE, Colo., September 15, 2026 – Danone USA is issuing a voluntary recall of So Delicious Dairy Free® Salted Caramel Cluster Non-Dairy Frozen Dessert pints with best-by dates on and before April 3, 2028 due to…",
      "status": "Recall",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration",
        "classification": null,
        "firm": null,
        "recallNumber": null
      },
      "jurisdiction": "US",
      "date": "2026-09-15T20:31:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "So Delicious Dairy Free® Issues Voluntary Recall of Salted Caramel Cluster Non-Dairy Frozen Dessert Pints Due to Potential Presence of Foreign Material",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/so-delicious-dairy-freer-issues-voluntary-recall-salted-caramel-cluster-non-dairy-frozen-dessert",
        "publisher": "U.S. Food and Drug Administration",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:08.752Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:22.194Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-09-15T20:31:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:30",
      "record": "Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Esophageal pH Monitoring Capsule Delivery Device",
      "subtitle": null,
      "detail": "The Medtronic and Given Imaging Bravo CF esophageal pH monitoring capsule can fail to attach to the esophagus or detach from its delivery device.",
      "status": "Safety alert",
      "fields": {
        "recordType": "Safety alert",
        "publisher": "U.S. Food and Drug Administration (MedWatch)"
      },
      "jurisdiction": "US",
      "date": "2026-09-15T04:00:00.000Z",
      "dateType": "Published",
      "source": {
        "title": "Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Esophageal pH Monitoring Capsule Delivery Device",
        "url": "https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/esophageal-ph-monitoring-capsule-recall-medtronic-and-given-imaging-remove-esophageal-ph-monitoring",
        "publisher": "U.S. Food and Drug Administration (MedWatch)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:09.176Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:23.259Z",
      "change": {
        "note": "Safety alert published",
        "at": "2026-09-15T04:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:13",
      "record": "A&P Creations LLC Issues Nationwide Recall of biQ-FEL Due to Undeclared Sildenafil and Tadalafil",
      "subtitle": null,
      "detail": "Sildenafil and Tadalafil are active ingredients in FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction. FDA approval of Viagra and Cialis is restricted to use under the supervision of a licen…",
      "status": "Recall",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration",
        "classification": null,
        "firm": null,
        "recallNumber": null
      },
      "jurisdiction": "US",
      "date": "2026-09-14T19:55:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "A&P Creations LLC Issues Nationwide Recall of biQ-FEL Due to Undeclared Sildenafil and Tadalafil",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ap-creations-llc-issues-nationwide-recall-biq-fel-due-undeclared-sildenafil-and-tadalafil",
        "publisher": "U.S. Food and Drug Administration",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:08.752Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:22.012Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-09-14T19:55:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:14",
      "record": "A&P Creations LLC Issues Nationwide Recall of X10 Natural Enhancement Supplement Due to Undeclared Sildenafil and Tadalafil",
      "subtitle": null,
      "detail": "Clermont, Florida – A&P Creations LLC is recalling X10 Natural Enhancement Supplement to the consumer level because it has been found to contain undeclared sildenafil and tadalafil.",
      "status": "Recall",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration",
        "classification": null,
        "firm": null,
        "recallNumber": null
      },
      "jurisdiction": "US",
      "date": "2026-09-14T19:06:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "A&P Creations LLC Issues Nationwide Recall of X10 Natural Enhancement Supplement Due to Undeclared Sildenafil and Tadalafil",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ap-creations-llc-issues-nationwide-recall-x10-natural-enhancement-supplement-due-undeclared",
        "publisher": "U.S. Food and Drug Administration",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:08.752Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:21.796Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-09-14T19:06:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:17",
      "record": "Centric Compounding Issues Nationwide Recall of Glutathione, Myer’s Cocktail, and Tri-Immune Boost Due to Elevated Endotoxin Levels",
      "subtitle": null,
      "detail": "FOR IMMEDIATE RELEASE – 9/9/2026 – Houston, Texas, Centric Compounding is voluntarily recalling 6 lots of Glutathione 200mg/mL, Myer’s Cocktail, and Tri-Immune Boost injectable vials to the consumer level. The products have been found to b…",
      "status": "Recall",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration",
        "classification": null,
        "firm": null,
        "recallNumber": null
      },
      "jurisdiction": "US",
      "date": "2026-09-11T15:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Centric Compounding Issues Nationwide Recall of Glutathione, Myer’s Cocktail, and Tri-Immune Boost Due to Elevated Endotoxin Levels",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/centric-compounding-issues-nationwide-recall-glutathione-myers-cocktail-and-tri-immune-boost-due",
        "publisher": "U.S. Food and Drug Administration",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:08.752Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:21.562Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-09-11T15:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:154",
      "record": "Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability",
      "subtitle": "Health and Human Services Department, Food and Drug Administration",
      "detail": "The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry titled \"Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates.\" This guidance desc…",
      "status": "Notice",
      "fields": {
        "recordType": "Notice",
        "publisher": "Federal Register",
        "documentNumber": "2026-18368",
        "agencies": "Health and Human Services Department, Food and Drug Administration"
      },
      "jurisdiction": "US",
      "date": "2026-09-09T00:00:00.000Z",
      "dateType": "Published in the Federal Register",
      "source": {
        "title": "Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability",
        "url": "https://www.federalregister.gov/documents/2026/09/09/2026-18368/temporary-policies-for-compounding-certain-starter-parenteral-nutrition-drug-products-for-neonates",
        "publisher": "Federal Register",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:13.506Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:30.576Z",
      "change": {
        "note": "Notice published",
        "at": "2026-09-09T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:19",
      "record": "FreshPoint Issues Recall Due to an Improperly Declared Allergen (Egg) in Chicken Salad Wedge Sandwiches",
      "subtitle": null,
      "detail": "September 4, 2026 Orlando, FL– FreshPoint of Orlando, FL., is issuing a voluntary recall of 1,093 units of specific lots of Cranberry Chicken Salad Wedge sandwiches due to an improperly declared allergen (eggs). People who have an allergy…",
      "status": "Recall",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration",
        "classification": null,
        "firm": null,
        "recallNumber": null
      },
      "jurisdiction": "US",
      "date": "2026-09-08T19:31:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "FreshPoint Issues Recall Due to an Improperly Declared Allergen (Egg) in Chicken Salad Wedge Sandwiches",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/freshpoint-issues-recall-due-improperly-declared-allergen-egg-chicken-salad-wedge-sandwiches",
        "publisher": "U.S. Food and Drug Administration",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:08.752Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:21.295Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-09-08T19:31:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:562",
      "record": "BMC Medical Co., Ltd. Recalls Luna G3 APAP (Model LG3600) Devices with Firmware G3-2.00.76 Configured with G3 A20-31.cfg",
      "subtitle": null,
      "detail": "On July 15, 2026, BMC Medical Co., Ltd. (BMC), Beijing, China, retrospectively reported to the US Food and Drug Administration (FDA) a recall of 20,160 Luna G3 APAP (Model LG3600) devices distributed in the United States due to firmware de…",
      "status": "Safety alert",
      "fields": {
        "recordType": "Safety alert",
        "publisher": "U.S. Food and Drug Administration (MedWatch)"
      },
      "jurisdiction": "US",
      "date": "2026-09-08T04:00:00.000Z",
      "dateType": "Published",
      "source": {
        "title": "BMC Medical Co., Ltd. Recalls Luna G3 APAP (Model LG3600) Devices with Firmware G3-2.00.76 Configured with G3 A20-31.cfg",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bmc-medical-co-ltd-recalls-luna-g3-apap-model-lg3600-devices-firmware-g3-20076-configured-g3-a20",
        "publisher": "U.S. Food and Drug Administration (MedWatch)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-02T17:05:01.483Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-02T17:05:01.911Z",
      "change": {
        "note": "Safety alert published",
        "at": "2026-09-08T04:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:20",
      "record": "BMC Medical Co., Ltd. Recalls Luna G3 APAP (Model LG3600) with Firmware G3-2.00.76 Due to Firmware Defect",
      "subtitle": null,
      "detail": "On July 15, 2026, BMC Medical Co., Ltd. (BMC), Beijing, China, retrospectively reported to the US Food and Drug Administration (FDA) a recall of 20,160 Luna G3 APAP (Model LG3600) devices distributed in the United States due to firmware de…",
      "status": "Recall",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration",
        "classification": null,
        "firm": null,
        "recallNumber": null
      },
      "jurisdiction": "US",
      "date": "2026-09-07T14:55:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "BMC Medical Co., Ltd. Recalls Luna G3 APAP (Model LG3600) with Firmware G3-2.00.76 Due to Firmware Defect",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bmc-medical-co-ltd-recalls-luna-g3-apap-model-lg3600-firmware-g3-20076-due-firmware-defect",
        "publisher": "U.S. Food and Drug Administration",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:08.752Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:21.235Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-09-07T14:55:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:33",
      "record": "Spinal Cord Stimulator Recall: Boston Scientific Removes Infinion CX Lead",
      "subtitle": null,
      "detail": "Infinion CX Lead bodies may experience mechanical stress at the anchor site resulting in inadequate stimulation requiring lead explant and replacement.",
      "status": "Safety alert",
      "fields": {
        "recordType": "Safety alert",
        "publisher": "U.S. Food and Drug Administration (MedWatch)"
      },
      "jurisdiction": "US",
      "date": "2026-09-03T04:00:00.000Z",
      "dateType": "Published",
      "source": {
        "title": "Spinal Cord Stimulator Recall: Boston Scientific Removes Infinion CX Lead",
        "url": "https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/spinal-cord-stimulator-recall-boston-scientific-removes-infinion-cx-lead",
        "publisher": "U.S. Food and Drug Administration (MedWatch)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:09.176Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:23.039Z",
      "change": {
        "note": "Safety alert published",
        "at": "2026-09-03T04:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:32",
      "record": "B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container Due to the Presence of Particulate Matter",
      "subtitle": null,
      "detail": "FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facilit…",
      "status": "Safety alert",
      "fields": {
        "recordType": "Safety alert",
        "publisher": "U.S. Food and Drug Administration (MedWatch)"
      },
      "jurisdiction": "US",
      "date": "2026-09-03T04:00:00.000Z",
      "dateType": "Published",
      "source": {
        "title": "B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container Due to the Presence of Particulate Matter",
        "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/b-braun-medical-inc-issues-voluntary-nationwide-recall-09-sodium-chloride-injection-usp-100-ml-150",
        "publisher": "U.S. Food and Drug Administration (MedWatch)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:09.176Z",
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      "subtitle": "Recall D-0753-2026",
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      "nphlaUpdatedAt": "2026-10-01T09:05:28.021Z",
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      "key": "item:93",
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      "key": "item:92",
      "record": "SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202…",
      "subtitle": "Recall D-0747-2026",
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      "key": "item:197",
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    {
      "key": "item:102",
      "record": "Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 4…",
      "subtitle": "Recall D-0541-2026",
      "detail": "Reason: Presence of particulate matter: a white thread-like structure in the cartridge",
      "status": "Class II · Ongoing",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "Lupin Pharmaceuticals Inc.",
        "recallNumber": "D-0541-2026"
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      "jurisdiction": "US",
      "date": "2026-05-27T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples,…",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0541-2026%22",
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      "lastChecked": "2026-10-01T09:05:12.028Z",
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      "nphlaUpdatedAt": "2026-10-01T09:05:27.678Z",
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        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-05-27T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
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    {
      "key": "item:166",
      "record": "Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act",
      "subtitle": "Health and Human Services Department, Food and Drug Administration",
      "detail": "The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are require…",
      "status": "Notice",
      "fields": {
        "recordType": "Notice",
        "publisher": "Federal Register",
        "documentNumber": "2026-10372",
        "agencies": "Health and Human Services Department, Food and Drug Administration"
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      "jurisdiction": "US",
      "date": "2026-05-26T00:00:00.000Z",
      "dateType": "Published in the Federal Register",
      "source": {
        "title": "Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act",
        "url": "https://www.federalregister.gov/documents/2026/05/26/2026-10372/agency-information-collection-activities-proposed-collection-comment-request-human-drug-compounding",
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        "type": "Official record"
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      "lastChecked": "2026-10-01T09:05:13.506Z",
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      "nphlaUpdatedAt": "2026-10-01T09:05:30.041Z",
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        "note": "Notice published",
        "at": "2026-05-26T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
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      "key": "item:169",
      "record": "List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act",
      "subtitle": "Health and Human Services Department, Food and Drug Administration",
      "detail": "The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourc…",
      "status": "Notice",
      "fields": {
        "recordType": "Notice",
        "publisher": "Federal Register",
        "documentNumber": "2026-08552",
        "agencies": "Health and Human Services Department, Food and Drug Administration"
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      "jurisdiction": "US",
      "date": "2026-05-01T00:00:00.000Z",
      "dateType": "Published in the Federal Register",
      "source": {
        "title": "List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act",
        "url": "https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal",
        "publisher": "Federal Register",
        "type": "Official record"
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      "lastChecked": "2026-10-01T09:05:13.506Z",
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      "nphlaUpdatedAt": "2026-10-01T09:05:29.894Z",
      "change": {
        "note": "Notice published",
        "at": "2026-05-01T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
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    {
      "key": "item:103",
      "record": "Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR",
      "subtitle": "Recall D-0471-2026",
      "detail": "Reason: Lack of Assurance of Sterility",
      "status": "Class II · Ongoing",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "PAYLESS COMPOUNDERS, LLC",
        "recallNumber": "D-0471-2026"
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      "jurisdiction": "US",
      "date": "2026-04-22T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest…",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0471-2026%22",
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      "lastChecked": "2026-10-01T09:05:12.028Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:27.641Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-04-22T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
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    {
      "key": "item:105",
      "record": "Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06",
      "subtitle": "Recall D-0393-2026",
      "detail": "Reason: Lack of Assurance of Sterility",
      "status": "Class II · Ongoing",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "New Life Pharma LLC",
        "recallNumber": "D-0393-2026"
      },
      "jurisdiction": "US",
      "date": "2026-03-11T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106,…",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0393-2026%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
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      "lastChecked": "2026-10-01T09:05:12.028Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:27.571Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-03-11T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
    },
    {
      "key": "item:104",
      "record": "Semaglutide,  For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d)…",
      "subtitle": "Recall D-0380-2026",
      "detail": "Reason: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution",
      "status": "Class II · Ongoing",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "Harbin Jixianglong Biotech Co., Ltd.",
        "recallNumber": "D-0380-2026"
      },
      "jurisdiction": "US",
      "date": "2026-03-11T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Semaglutide,  For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c)…",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0380-2026%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
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      "lastChecked": "2026-10-01T09:05:12.028Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:27.607Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2026-03-11T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
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    {
      "key": "item:106",
      "record": "PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection, a) 1440 mL bag, b) 1700 mL bag, Centra…",
      "subtitle": "Recall D-0530-2025",
      "detail": "Reason: Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.",
      "status": "Class II · Ongoing",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "Central Admixture Pharmacy Services, Inc (CAPS)  Los Angeles",
        "recallNumber": "D-0530-2025"
      },
      "jurisdiction": "US",
      "date": "2025-07-23T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single…",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0530-2025%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
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      "lastChecked": "2026-10-01T09:05:12.440Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:28.714Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2025-07-23T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:107",
      "record": "HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701,  NDC 7301…",
      "subtitle": "Recall D-0385-2025",
      "detail": "Reason: Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..",
      "status": "Class III · Terminated",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class III",
        "firm": "OurPharma LLC",
        "recallNumber": "D-0385-2025"
      },
      "jurisdiction": "US",
      "date": "2025-04-30T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class III recall: HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512…",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0385-2025%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
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      "lastChecked": "2026-10-01T09:05:12.440Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:28.676Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2025-04-30T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
    },
    {
      "key": "item:108",
      "record": "Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massa…",
      "subtitle": "Recall D-0778-2023",
      "detail": "Reason: Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride",
      "status": "Class III · Terminated",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class III",
        "firm": "New England Life Care, Inc. dba Advanced Compounding Solutions",
        "recallNumber": "D-0778-2023"
      },
      "jurisdiction": "US",
      "date": "2023-06-07T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class III recall: Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced…",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0778-2023%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
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      "lastChecked": "2026-10-01T09:05:12.440Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:28.633Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2023-06-07T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
    },
    {
      "key": "item:120",
      "record": "Sildenafil 200 mg Troche (Clinic)",
      "subtitle": "Recall D-0814-2020",
      "detail": "Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.",
      "status": "Class II · Terminated",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "MPRX, Inc. dba Medical Park Pharmacy",
        "recallNumber": "D-0814-2020"
      },
      "jurisdiction": "US",
      "date": "2020-02-05T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Sildenafil 200 mg Troche (Clinic)",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0814-2020%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
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      "lastChecked": "2026-10-01T09:05:12.440Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:28.173Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2020-02-05T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
    },
    {
      "key": "item:119",
      "record": "Magic Bullet Supplement",
      "subtitle": "Recall D-0809-2020",
      "detail": "Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.",
      "status": "Class II · Terminated",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "MPRX, Inc. dba Medical Park Pharmacy",
        "recallNumber": "D-0809-2020"
      },
      "jurisdiction": "US",
      "date": "2020-02-05T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Magic Bullet Supplement",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0809-2020%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
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      "lastChecked": "2026-10-01T09:05:12.440Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:28.215Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2020-02-05T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
    },
    {
      "key": "item:118",
      "record": "Finasteride/Biotin 1 mg/50 mcg",
      "subtitle": "Recall D-0804-2020",
      "detail": "Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.",
      "status": "Class II · Terminated",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "MPRX, Inc. dba Medical Park Pharmacy",
        "recallNumber": "D-0804-2020"
      },
      "jurisdiction": "US",
      "date": "2020-02-05T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Finasteride/Biotin 1 mg/50 mcg",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0804-2020%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
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      "lastChecked": "2026-10-01T09:05:12.440Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:28.253Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2020-02-05T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
    },
    {
      "key": "item:117",
      "record": "Testosterone Topical Cream 4%",
      "subtitle": "Recall D-0820-2020",
      "detail": "Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.",
      "status": "Class II · Terminated",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "MPRX, Inc. dba Medical Park Pharmacy",
        "recallNumber": "D-0820-2020"
      },
      "jurisdiction": "US",
      "date": "2020-02-05T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Testosterone Topical Cream 4%",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0820-2020%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
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      "lastChecked": "2026-10-01T09:05:12.440Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:28.290Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2020-02-05T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
    },
    {
      "key": "item:116",
      "record": "Progesterone E4M SR 100 mg capsules",
      "subtitle": "Recall D-0813-2020",
      "detail": "Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.",
      "status": "Class II · Terminated",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "MPRX, Inc. dba Medical Park Pharmacy",
        "recallNumber": "D-0813-2020"
      },
      "jurisdiction": "US",
      "date": "2020-02-05T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Progesterone E4M SR 100 mg capsules",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0813-2020%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
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      "lastChecked": "2026-10-01T09:05:12.440Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:28.326Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2020-02-05T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
    },
    {
      "key": "item:115",
      "record": "Sildenafil 80 mg capsules",
      "subtitle": "Recall D-0815-2020",
      "detail": "Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.",
      "status": "Class II · Terminated",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "MPRX, Inc. dba Medical Park Pharmacy",
        "recallNumber": "D-0815-2020"
      },
      "jurisdiction": "US",
      "date": "2020-02-05T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Sildenafil 80 mg capsules",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0815-2020%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
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      "lastChecked": "2026-10-01T09:05:12.440Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:28.364Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2020-02-05T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:114",
      "record": "Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars",
      "subtitle": "Recall D-0806-2020",
      "detail": "Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.",
      "status": "Class II · Terminated",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "MPRX, Inc. dba Medical Park Pharmacy",
        "recallNumber": "D-0806-2020"
      },
      "jurisdiction": "US",
      "date": "2020-02-05T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0806-2020%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
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      "lastChecked": "2026-10-01T09:05:12.440Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:28.404Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2020-02-05T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
    },
    {
      "key": "item:113",
      "record": "Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars",
      "subtitle": "Recall D-0805-2020",
      "detail": "Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.",
      "status": "Class II · Terminated",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "MPRX, Inc. dba Medical Park Pharmacy",
        "recallNumber": "D-0805-2020"
      },
      "jurisdiction": "US",
      "date": "2020-02-05T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0805-2020%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:12.440Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:28.445Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2020-02-05T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:112",
      "record": "Naltrexone 4.5 mg capsule",
      "subtitle": "Recall D-0810-2020",
      "detail": "Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.",
      "status": "Class II · Terminated",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "MPRX, Inc. dba Medical Park Pharmacy",
        "recallNumber": "D-0810-2020"
      },
      "jurisdiction": "US",
      "date": "2020-02-05T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Naltrexone 4.5 mg capsule",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0810-2020%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:12.440Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:28.485Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2020-02-05T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:111",
      "record": "Tadalafil 6 mg Capsule",
      "subtitle": "Recall D-0819-2020",
      "detail": "Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.",
      "status": "Class II · Terminated",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "MPRX, Inc. dba Medical Park Pharmacy",
        "recallNumber": "D-0819-2020"
      },
      "jurisdiction": "US",
      "date": "2020-02-05T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Tadalafil 6 mg Capsule",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0819-2020%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:12.440Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:28.521Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2020-02-05T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:110",
      "record": "Progesterone 200 mg Troche",
      "subtitle": "Recall D-0811-2020",
      "detail": "Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.",
      "status": "Class II · Terminated",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "MPRX, Inc. dba Medical Park Pharmacy",
        "recallNumber": "D-0811-2020"
      },
      "jurisdiction": "US",
      "date": "2020-02-05T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Progesterone 200 mg Troche",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0811-2020%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
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      "lastChecked": "2026-10-01T09:05:12.440Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:28.558Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2020-02-05T00:00:00.000Z",
        "withinLast7Days": false
      },
      "origin": "automated"
    },
    {
      "key": "item:109",
      "record": "Squaric Acid 0.1% Topical Solution (Clinic) 30 mL",
      "subtitle": "Recall D-0816-2020",
      "detail": "Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.",
      "status": "Class II · Terminated",
      "fields": {
        "recordType": "Recall",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "classification": "Class II",
        "firm": "MPRX, Inc. dba Medical Park Pharmacy",
        "recallNumber": "D-0816-2020"
      },
      "jurisdiction": "US",
      "date": "2020-02-05T00:00:00.000Z",
      "dateType": "Enforcement report date",
      "source": {
        "title": "Class II recall: Squaric Acid 0.1% Topical Solution (Clinic) 30 mL",
        "url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0816-2020%22",
        "publisher": "U.S. Food and Drug Administration (Enforcement Report)",
        "type": "Official record"
      },
      "lastChecked": "2026-10-01T09:05:12.440Z",
      "checkedBy": "system",
      "nphlaUpdatedAt": "2026-10-01T09:05:28.595Z",
      "change": {
        "note": "Recall published in the FDA Enforcement Report",
        "at": "2020-02-05T00:00:00.000Z",
        "withinLast7Days": false
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      "origin": "automated"
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  ]
}