NPHLA Tracker · Compounding regulatory tracker (Federal Register / FDA)
Compounding Regulatory Tracker
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.
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- Records
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- Jurisdiction
- United States (federal)
Records
98 records| Record | Status | Record type | Jurisdiction | Date | Source | Last checked |
|---|---|---|---|---|---|---|
| Medline Updates Customers and Patients on Repair and Replace Program for Recall of Medline Brand Beds, Rails, Mattresses and AccessoriesChanged in the last 7 days Recall published in the FDA Enforcement Report · 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… | Recall | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration: Medline Updates Customers and Patients on Repair and Replace Program for Recall of Medline Brand Beds, Rails, Mattresses and Accessories (opens in a new tab)Official record | System checked NPHLA updated |
| Eros Apothecary Issues Recall of Candy Power For Man Organic Honey Due to Undeclared TadalafilChanged in the last 7 days Recall published in the FDA Enforcement Report · Eros Apothecary of Indio, California is recalling Candy Power For Man Organic Honey because the product was found to contain undeclared tadalafil. | Recall | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration: Eros Apothecary Issues Recall of Candy Power For Man Organic Honey Due to Undeclared Tadalafil (opens in a new tab)Official record | System checked NPHLA updated |
| Game Changer Products LLC Issues Voluntary Nationwide Recall of 10 Day Forecast Capsules Due to the Presence of Undeclared Sildenafil and AcetaminophenChanged in the last 7 days Safety alert published · 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… | Safety alert | Safety alert | United States (federal) | Published | U.S. Food and Drug Administration (MedWatch): Game Changer Products LLC Issues Voluntary Nationwide Recall of 10 Day Forecast Capsules Due to the Presence of Undeclared Sildenafil and Acetaminophen (opens in a new tab)Official record | System checked NPHLA updated |
| Family Farmstead Dairy Announces Recall of All Cheddar Cheese Products Because of Possible Health RiskChanged in the last 7 days Recall published in the FDA Enforcement Report · 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… | Recall | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration: Family Farmstead Dairy Announces Recall of All Cheddar Cheese Products Because of Possible Health Risk (opens in a new tab)Official record | System checked NPHLA updated |
| 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 CommunicationChanged in the last 7 days Safety alert published · 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 | Safety alert | Safety alert | United States (federal) | Published | U.S. Food and Drug Administration (MedWatch): 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 (opens in a new tab)Official record | System checked NPHLA updated |
| Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers (AIC)Changed in the last 7 days Safety alert published · Abiomed is removing certain Impella Controllers with various hardware, firmware, and/or software updates based on a retrospective review of servicing records. | Safety alert | Safety alert | United States (federal) | Published | U.S. Food and Drug Administration (MedWatch): Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers (AIC) (opens in a new tab)Official record | System checked NPHLA updated |
| 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 MatterFOR 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)… | Recall | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration: 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 (opens in a new tab)Official record | System checked NPHLA updated |
| Platelet Factor 4 (PF4) Radioimmunoassay Recall: Instrumentation Laboratories Removes HemosIL AcuStar HIT-IgG(PF4-H)Product performance issue may lead to a false negative result which will delay recognition of heparin-induced thrombocytopenia. | Safety alert | Safety alert | United States (federal) | Published | U.S. Food and Drug Administration (MedWatch): Platelet Factor 4 (PF4) Radioimmunoassay Recall: Instrumentation Laboratories Removes HemosIL AcuStar HIT-IgG(PF4-H) (opens in a new tab)Official record | System checked NPHLA updated |
| Taylor Farms Issues Recall for H-E-B Backyard BBQ Chop Salad Kit Due to the Potential Undeclared Soy and Tree Nuts(Almonds)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). | Recall | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration: Taylor Farms Issues Recall for H-E-B Backyard BBQ Chop Salad Kit Due to the Potential Undeclared Soy and Tree Nuts(Almonds) (opens in a new tab)Official record | System checked NPHLA updated |
| Tonight We Ride, LLC Issues Voluntary Recall of Ultimate Forza Male Supplement Due to Presence of Undeclared Sildenafil, Tadalafil, and DapoxetineOctober 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… | Recall | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration: Tonight We Ride, LLC Issues Voluntary Recall of Ultimate Forza Male Supplement Due to Presence of Undeclared Sildenafil, Tadalafil, and Dapoxetine (opens in a new tab)Official record | System checked NPHLA updated |
| Wedgewood Pharmacy Issues Recall of Certain Compounded Veterinary Medications Within Expiry Due to Potential Potency IssuesSWEDESBORO, 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… | Safety alert | Safety alert | United States (federal) | Published | U.S. Food and Drug Administration (MedWatch): Wedgewood Pharmacy Issues Recall of Certain Compounded Veterinary Medications Within Expiry Due to Potential Potency Issues (opens in a new tab)Official record | System checked NPHLA updated |
| 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.Recall D-0040-2027Reason: Lack of assurance of sterility. | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage… (opens in a new tab)Official record | System checked NPHLA updated |
| Update: Import Alert for Certain Olympus Medical Devices Manufactured in Japan - Letter to Health Care ProvidersThe 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. | Safety alert | Safety alert | United States (federal) | Published | U.S. Food and Drug Administration (MedWatch): Update: Import Alert for Certain Olympus Medical Devices Manufactured in Japan - Letter to Health Care Providers (opens in a new tab)Official record | System checked NPHLA updated |
| Import Alert for Certain Olympus Medical Devices Manufactured in Japan - Letter to Health Care ProvidersThe 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. | Safety alert | Safety alert | United States (federal) | Published | U.S. Food and Drug Administration (MedWatch): Import Alert for Certain Olympus Medical Devices Manufactured in Japan - Letter to Health Care Providers (opens in a new tab)Official record | System checked NPHLA updated |
| Family Farmstead Dairy Announces Recall of Raw Mild Cheddar Cheese Due to Potential E. coli O26:H11 and O45:H2 ContaminationWORCESTER, 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… | Recall | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration: Family Farmstead Dairy Announces Recall of Raw Mild Cheddar Cheese Due to Potential E. coli O26:H11 and O45:H2 Contamination (opens in a new tab)Official record | System checked NPHLA updated |
| Family Farmstead Dairy Announces Recall of Raw Mild Cheddar Cheese Due to Potential E. coli O157:H7 ContaminationWORCESTER, 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… | Recall | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration: Family Farmstead Dairy Announces Recall of Raw Mild Cheddar Cheese Due to Potential E. coli O157:H7 Contamination (opens in a new tab)Official record | System checked NPHLA updated |
| Par Health Issues Voluntary Nationwide Recall of Argatroban Injection Due to the Presence of Particulate MatterFOR IMMEDIATE RELEASE - ROCHESTER, MI– October 13, 2026 – Par Health is recalling 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) to the hospital/user level. This recall is being conducted due to the presence of particulate matte… | Safety alert | Safety alert | United States (federal) | Published | U.S. Food and Drug Administration (MedWatch): Par Health Issues Voluntary Nationwide Recall of Argatroban Injection Due to the Presence of Particulate Matter (opens in a new tab)Official record | System checked NPHLA updated |
| Convenience Kit Recall: AVID Medical Removes Convenience Kits Affected by BD ChloraPrep Applicator RecallAvid Medical is removing certain convenience kits affected by the BD ChloraPrep Applicator Recall that may be contaminated with Aspergillus penicillioides. | Safety alert | Safety alert | United States (federal) | Published | U.S. Food and Drug Administration (MedWatch): Convenience Kit Recall: AVID Medical Removes Convenience Kits Affected by BD ChloraPrep Applicator Recall (opens in a new tab)Official record | System checked NPHLA updated |
| Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC 27513, NDC 85091-001-18.Recall D-0036-2027Reason: Lack of Assurance of Sterility | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans… (opens in a new tab)Official record | System checked NPHLA updated |
| SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936Recall D-0018-2027Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland,… (opens in a new tab)Official record | System checked NPHLA updated |
| SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription,…Recall D-0019-2027Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed… (opens in a new tab)Official record | System checked NPHLA updated |
| SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription,…Recall D-0026-2027Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed… (opens in a new tab)Official record | System checked NPHLA updated |
| TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusio…Recall D-0017-2027Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage… (opens in a new tab)Official record | System checked NPHLA updated |
| TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription,…Recall D-0029-2027Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed… (opens in a new tab)Official record | System checked NPHLA updated |
| TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription,…Recall D-0028-2027Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed… (opens in a new tab)Official record | System checked NPHLA updated |
| TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription,…Recall D-0030-2027Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed… (opens in a new tab)Official record | System checked NPHLA updated |
| 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…Recall D-0031-2027Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, Packaged in single-use dosage syringes, total mL… (opens in a new tab)Official record | System checked NPHLA updated |
| 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…Recall D-0024-2027Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product. | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use dosage syringes, total mL… (opens in a new tab)Official record | System checked NPHLA updated |
| 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…Recall D-0032-2027Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on… (opens in a new tab)Official record | System checked NPHLA updated |
| 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…Recall D-0025-2027Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product. | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes, total mL… (opens in a new tab)Official record | System checked NPHLA updated |
| 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…Recall D-0023-2027Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product. | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use dosage syringes, total mL… (opens in a new tab)Official record | System checked NPHLA updated |
| 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…Recall D-0022-2027Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product. | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL… (opens in a new tab)Official record | System checked NPHLA updated |
| TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription,…Recall D-0027-2027Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed… (opens in a new tab)Official record | System checked NPHLA updated |
| QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, C…Recall D-0021-2027Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product. | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed… (opens in a new tab)Official record | System checked NPHLA updated |
| Convenience Kit Recall: Medline Removes Convenience Kits Affected by BD ChloraPrep Applicator RecallCertain Medline convenience kits containing recalled BD ChloraPrep applicators should be removed from use due to potential fungal contamination | Safety alert | Safety alert | United States (federal) | Published | U.S. Food and Drug Administration (MedWatch): Convenience Kit Recall: Medline Removes Convenience Kits Affected by BD ChloraPrep Applicator Recall (opens in a new tab)Official record | System checked NPHLA updated |
| 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 MatterFOR 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… | Safety alert | Safety alert | United States (federal) | Published | U.S. Food and Drug Administration (MedWatch): 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 (opens in a new tab)Official record | System checked NPHLA updated |
| Leader Formulas, LLC. Issues Voluntary Nationwide Recall of RAPTURE Preworkout Due to the Presence of 1,3-Dimethylamylamine (DMAA)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… | Recall | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration: Leader Formulas, LLC. Issues Voluntary Nationwide Recall of RAPTURE Preworkout Due to the Presence of 1,3-Dimethylamylamine (DMAA) (opens in a new tab)Official record | System checked NPHLA updated |
| Infusion Set Recall: BD and CareFusion 303, Inc. Remove BD Alaris Pump Infusion SetsBD Alaris Pump Infusion Sets are being removed and discontinued; Alaris Pump Module model 8100 has updated performance data | Safety alert | Safety alert | United States (federal) | Published | U.S. Food and Drug Administration (MedWatch): Infusion Set Recall: BD and CareFusion 303, Inc. Remove BD Alaris Pump Infusion Sets (opens in a new tab)Official record | System checked NPHLA updated |
| 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 O145October 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… | Recall | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration: 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 (opens in a new tab)Official record | System checked NPHLA updated |
| Flowers Foods Issues Recall of Nature’s Own Hawaiian Bread Due to Undeclared MilkTHOMASVILLE, 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… | Recall | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration: Flowers Foods Issues Recall of Nature’s Own Hawaiian Bread Due to Undeclared Milk (opens in a new tab)Official record | System checked NPHLA updated |
| Breathing Circuit Recall: Draeger Removes VentStar Resus Neo HosesRemoval of VentStar Resus Neo hoses due to the potential for cracks resulting in restricted ventilation or delayed therapy. | Safety alert | Safety alert | United States (federal) | Published | U.S. Food and Drug Administration (MedWatch): Breathing Circuit Recall: Draeger Removes VentStar Resus Neo Hoses (opens in a new tab)Official record | System checked NPHLA updated |
| 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 AllergenCincinnati, 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… | Recall | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration: 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 (opens in a new tab)Official record | System checked NPHLA updated |
| Greenwich Rx Issues Voluntary Nationwide Recall of Compounded Glutathione Due to Elevated Endotoxin LevelsIMMEDIATE 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… | Safety alert | Safety alert | United States (federal) | Published | U.S. Food and Drug Administration (MedWatch): Greenwich Rx Issues Voluntary Nationwide Recall of Compounded Glutathione Due to Elevated Endotoxin Levels (opens in a new tab)Official record | System checked NPHLA updated |
| G. L. Mezzetta Inc. Announces Recall of Mezzetta Brand Golden Greek Peperoncini (Medium Heat) Due to Presence of Pest Contaminant in the JarFor 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… | Recall | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration: G. L. Mezzetta Inc. Announces Recall of Mezzetta Brand Golden Greek Peperoncini (Medium Heat) Due to Presence of Pest Contaminant in the Jar (opens in a new tab)Official record | System checked NPHLA updated |
| Angiographic Catheter Recall: Boston Scientific Removes Imager II Angiographic CathetersBoston Scientific Imager II Angiographic Catheters removed due to a manufacturing issue leading to tip detachment; could result in procedural delays, embolism | Safety alert | Safety alert | United States (federal) | Published | U.S. Food and Drug Administration (MedWatch): Angiographic Catheter Recall: Boston Scientific Removes Imager II Angiographic Catheters (opens in a new tab)Official record | System checked NPHLA updated |
| Heart Pump Controller Recall: Abiomed Removes Automated Impella ControllersAbiomed is removing Automated Impella Controllers due to purge cassette recognition failures that may lead to prolonged delayed in mechanical circulatory support. | Safety alert | Safety alert | United States (federal) | Published | U.S. Food and Drug Administration (MedWatch): Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers (opens in a new tab)Official record | System checked NPHLA updated |
| Federal Court Enters Consent Decree Against Gold Star Distribution, Inc. Following Persistent Insanitary Warehouse ConditionsA 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… | Press release | Press release | United States (federal) | Published | U.S. Food and Drug Administration: Federal Court Enters Consent Decree Against Gold Star Distribution, Inc. Following Persistent Insanitary Warehouse Conditions (opens in a new tab)Primary source | System checked NPHLA updated |
| Ventilator Recall: CooperSurgical Removes INCA Infant Nasal CPAP SetsThe cannula sets may exhibit a loose connection between the flexible tubing and the nasal cannula resulting in reduced effectiveness and decreased oxygenation. | Safety alert | Safety alert | United States (federal) | Published | U.S. Food and Drug Administration (MedWatch): Ventilator Recall: CooperSurgical Removes INCA Infant Nasal CPAP Sets (opens in a new tab)Official record | System checked NPHLA updated |
| Par Health Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection Due to the Presence of Particulate MatterROCHESTER, 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… | Recall | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration: 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 (opens in a new tab)Official record | System checked NPHLA updated |
| Sodium Chloride Flush Recall: Spectra Medical Removes Sodium Chloride Injection USP AmpulesSpectra Medical Devices is removing Sodium Chloride Flush products that were manufactured by Huons Co,. Ltd. | Safety alert | Safety alert | United States (federal) | Published | U.S. Food and Drug Administration (MedWatch): Sodium Chloride Flush Recall: Spectra Medical Removes Sodium Chloride Injection USP Ampules (opens in a new tab)Official record | System checked NPHLA updated |
How is this tracker compiled?
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.
This tracker lists records from primary sources tagged with a compounding topic. News and trade-press items are excluded.
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.
What does it cover?
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.
What are its 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.
How often is it updated?
Sources are checked every 1 to 6 hours depending on the source, as configured in the Source Registry.
System checked is the last time an automated check of the underlying official sources succeeded — it is not a human review. Editorially reviewed appears only when an editor has reviewed this tracker. Each row shows its own check: an automated system check or an editor’s verification.
Data origin: NPHLA analysis of public data. Professional reference only — not medical, legal or regulatory advice. Always confirm a record in its primary source. Spotted an error? Tell us.