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
- 54
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- 2
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- Jurisdiction
- United States (federal)
Records
54 records| Record | Status | Record type | Jurisdiction | Date | Source | Last checked |
|---|---|---|---|---|---|---|
| G. L. Mezzetta Inc. Announces Recall of Mezzetta Brand Golden Greek Peperoncini (Medium Heat) Due to Presence of Pest Contaminant in the JarChanged in the last 7 days Recall published in the FDA Enforcement Report · 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… | 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 CathetersChanged in the last 7 days Safety alert published · Boston 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 |
| 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 InjectionOtsuka 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… | Recall | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration: 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 (opens in a new tab)Official record | System checked NPHLA updated |
| So Delicious Dairy Free® Issues Voluntary Recall of Salted Caramel Cluster Non-Dairy Frozen Dessert Pints Due to Potential Presence of Foreign MaterialWHITE 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… | Recall | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration: So Delicious Dairy Free® Issues Voluntary Recall of Salted Caramel Cluster Non-Dairy Frozen Dessert Pints Due to Potential Presence of Foreign Material (opens in a new tab)Official record | System checked NPHLA updated |
| Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Esophageal pH Monitoring Capsule Delivery DeviceThe Medtronic and Given Imaging Bravo CF esophageal pH monitoring capsule can fail to attach to the esophagus or detach from its delivery device. | Safety alert | Safety alert | United States (federal) | Published | U.S. Food and Drug Administration (MedWatch): Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Esophageal pH Monitoring Capsule Delivery Device (opens in a new tab)Official record | System checked NPHLA updated |
| A&P Creations LLC Issues Nationwide Recall of biQ-FEL Due to Undeclared Sildenafil and TadalafilSildenafil 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… | Recall | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration: A&P Creations LLC Issues Nationwide Recall of biQ-FEL Due to Undeclared Sildenafil and Tadalafil (opens in a new tab)Official record | System checked NPHLA updated |
| A&P Creations LLC Issues Nationwide Recall of X10 Natural Enhancement Supplement Due to Undeclared Sildenafil and TadalafilClermont, 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. | Recall | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration: A&P Creations LLC Issues Nationwide Recall of X10 Natural Enhancement Supplement Due to Undeclared Sildenafil and Tadalafil (opens in a new tab)Official record | System checked NPHLA updated |
| Centric Compounding Issues Nationwide Recall of Glutathione, Myer’s Cocktail, and Tri-Immune Boost Due to Elevated Endotoxin LevelsFOR 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… | Recall | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration: Centric Compounding Issues Nationwide Recall of Glutathione, Myer’s Cocktail, and Tri-Immune Boost Due to Elevated Endotoxin Levels (opens in a new tab)Official record | System checked NPHLA updated |
| Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; AvailabilityHealth and Human Services Department, Food and Drug AdministrationThe 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… | Notice | Notice | United States (federal) | Published in the Federal Register | Federal Register: Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability (opens in a new tab)Official record | System checked NPHLA updated |
| FreshPoint Issues Recall Due to an Improperly Declared Allergen (Egg) in Chicken Salad Wedge SandwichesSeptember 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… | Recall | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration: FreshPoint Issues Recall Due to an Improperly Declared Allergen (Egg) in Chicken Salad Wedge Sandwiches (opens in a new tab)Official record | System checked NPHLA updated |
| BMC Medical Co., Ltd. Recalls Luna G3 APAP (Model LG3600) with Firmware G3-2.00.76 Due to Firmware DefectOn 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… | Recall | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration: BMC Medical Co., Ltd. Recalls Luna G3 APAP (Model LG3600) with Firmware G3-2.00.76 Due to Firmware Defect (opens in a new tab)Official record | System checked NPHLA updated |
| Spinal Cord Stimulator Recall: Boston Scientific Removes Infinion CX LeadInfinion CX Lead bodies may experience mechanical stress at the anchor site resulting in inadequate stimulation requiring lead explant and replacement. | Safety alert | Safety alert | United States (federal) | Published | U.S. Food and Drug Administration (MedWatch): Spinal Cord Stimulator Recall: Boston Scientific Removes Infinion CX Lead (opens in a new tab)Official record | System checked NPHLA updated |
| 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 MatterFOR 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… | Safety alert | Safety alert | United States (federal) | Published | U.S. Food and Drug Administration (MedWatch): 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 (opens in a new tab)Official record | System checked NPHLA updated |
| Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound CathetersCertain reprocessed catheters may contain residual particulates that could cause infection, embolism, or thrombosis | Safety alert | Safety alert | United States (federal) | Published | U.S. Food and Drug Administration (MedWatch): Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters (opens in a new tab)Official record | System checked NPHLA updated |
| Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated FeesHealth and Human Services Department, Food and Drug AdministrationThe 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… | Notice | Notice | United States (federal) | Published in the Federal Register | Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees (opens in a new tab)Official record | System checked NPHLA updated |
| Compounding Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment RequestHealth and Human Services Department, Food and Drug AdministrationThe Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #256B entitled "Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered… | Notice | Notice | United States (federal) | Published in the Federal Register | Federal Register: Compounding Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request (opens in a new tab)Official record | System checked NPHLA updated |
| SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102,…Recall D-0754-2026Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous… (opens in a new tab)Official record | System checked NPHLA updated |
| SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202…Recall D-0750-2026Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only,… (opens in a new tab)Official record | System checked NPHLA updated |
| SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202.…Recall D-0751-2026Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO… (opens in a new tab)Official record | System checked NPHLA updated |
| SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102…Recall D-0756-2026Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous… (opens in a new tab)Official record | System checked NPHLA updated |
| SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102…Recall D-0757-2026Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous… (opens in a new tab)Official record | System checked NPHLA updated |
| SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202…Recall D-0752-2026Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only,… (opens in a new tab)Official record | System checked NPHLA updated |
| SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65…Recall D-0749-2026Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only,… (opens in a new tab)Official record | System checked NPHLA updated |
| SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste…Recall D-0753-2026Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For… (opens in a new tab)Official record | System checked NPHLA updated |
| SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65…Recall D-0748-2026Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only,… (opens in a new tab)Official record | System checked NPHLA updated |
| 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…Recall D-0747-2026Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only,… (opens in a new tab)Official record | System checked NPHLA updated |
| SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste…Recall D-0755-2026Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For… (opens in a new tab)Official record | System checked NPHLA updated |
| Outsourcing Facility Fee Rates for Fiscal Year 2027Health and Human Services Department, Food and Drug AdministrationThe Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2027 rates for the establishment and reinspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the… | Notice | Notice | United States (federal) | Published in the Federal Register | Federal Register: Outsourcing Facility Fee Rates for Fiscal Year 2027 (opens in a new tab)Official record | System checked NPHLA updated |
| 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…Recall D-0541-2026Reason: Presence of particulate matter: a white thread-like structure in the cartridge | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples,… (opens in a new tab)Official record | System checked NPHLA updated |
| Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic ActHealth and Human Services Department, Food and Drug AdministrationThe 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… | Notice | Notice | United States (federal) | Published in the Federal Register | Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (opens in a new tab)Official record | System checked NPHLA updated |
| List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic ActHealth and Human Services Department, Food and Drug AdministrationThe 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… | Notice | Notice | United States (federal) | Published in the Federal Register | Federal Register: List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act (opens in a new tab)Official record | System checked NPHLA updated |
| Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, ORRecall D-0471-2026Reason: 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: Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest… (opens in a new tab)Official record | System checked NPHLA updated |
| Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06Recall D-0393-2026Reason: 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: Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106,… (opens in a new tab)Official record | System checked NPHLA updated |
| 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)…Recall D-0380-2026Reason: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c)… (opens in a new tab)Official record | System checked NPHLA updated |
| PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection, a) 1440 mL bag, b) 1700 mL bag, Centra…Recall D-0530-2025Reason: 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. | Class II · Ongoing | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single… (opens in a new tab)Official record | System checked NPHLA updated |
| 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…Recall D-0385-2025Reason: Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification.. | Class III · Terminated | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class III recall: HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512… (opens in a new tab)Official record | System checked NPHLA updated |
| 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…Recall D-0778-2023Reason: Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride | Class III · Terminated | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class III recall: Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced… (opens in a new tab)Official record | System checked NPHLA updated |
| Sildenafil 200 mg Troche (Clinic)Recall D-0814-2020Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | Class II · Terminated | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: Sildenafil 200 mg Troche (Clinic) (opens in a new tab)Official record | System checked NPHLA updated |
| Magic Bullet SupplementRecall D-0809-2020Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | Class II · Terminated | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: Magic Bullet Supplement (opens in a new tab)Official record | System checked NPHLA updated |
| Finasteride/Biotin 1 mg/50 mcgRecall D-0804-2020Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | Class II · Terminated | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: Finasteride/Biotin 1 mg/50 mcg (opens in a new tab)Official record | System checked NPHLA updated |
| Testosterone Topical Cream 4%Recall D-0820-2020Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | Class II · Terminated | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: Testosterone Topical Cream 4% (opens in a new tab)Official record | System checked NPHLA updated |
| Progesterone E4M SR 100 mg capsulesRecall D-0813-2020Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | Class II · Terminated | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: Progesterone E4M SR 100 mg capsules (opens in a new tab)Official record | System checked NPHLA updated |
| Sildenafil 80 mg capsulesRecall D-0815-2020Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | Class II · Terminated | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: Sildenafil 80 mg capsules (opens in a new tab)Official record | System checked NPHLA updated |
| Lidocaine/Priloc/PE 30/5/0.25% 30 GM jarsRecall D-0806-2020Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | Class II · Terminated | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars (opens in a new tab)Official record | System checked NPHLA updated |
| Lidocaine/Priloc/PE 15/5/0.25% 30 GM jarsRecall D-0805-2020Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | Class II · Terminated | Recall | United States (federal) | Enforcement report date | U.S. Food and Drug Administration (Enforcement Report): Class II recall: Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars (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.