Browse Drug Recalls

112 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 112 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 112 FDA drug recalls.

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DateProductReasonClassFirm
Mar 16, 2026 Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60... Failed tablet specifications. Class II Amerisource Health Services LLC
Jan 14, 2026 Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) bliste... Defective container: Multiple customer complaints received for card seal defects observed on the ... Class II Amerisource Health Services LLC
Oct 16, 2025 Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx... Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the ... Class II Amerisource Health Services LLC
Oct 16, 2025 Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx... Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the ... Class II Amerisource Health Services LLC
Oct 16, 2025 Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx on... Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the ... Class II Amerisource Health Services LLC
Oct 9, 2025 Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by... CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it c... Class II Amerisource Health Services LLC
Sep 15, 2025 Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x... Failed Dissolution Specifications. Class II Amerisource Health Services LLC
Aug 27, 2025 chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) bl... Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... Class II Amerisource Health Services LLC
Aug 27, 2025 chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack pe... Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... Class II Amerisource Health Services LLC
Aug 27, 2025 chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, R... Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... Class II Amerisource Health Services LLC
Aug 27, 2025 chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack pe... Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... Class II Amerisource Health Services LLC
Jul 29, 2025 Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by... CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it canno... Class II Amerisource Health Services LLC
May 15, 2025 Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blist... cGMP deviations Class II Amerisource Health Services LLC
Mar 24, 2025 Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 i... cGMP Deviations: Received notification from their supplier requesting they perform a recall due t... Class II Amerisource Health Services LLC
Jan 7, 2025 Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister card... Presence of Foreign Tablets/Capsules Class II Amerisource Health Services LLC
Dec 17, 2024 glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) ca... Failed Dissolution Specifications: Class II Amerisource Health Services LLC
Dec 13, 2024 Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister card... Presence of Foreign Tablets/Capsules Class II Amerisource Health Services LLC
Jun 24, 2024 buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg,... Failed Dissolution Specifications; the product is dissolving faster than the specified limits. Class II Amerisource Health Services LLC
May 16, 2024 Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Risin... Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Pack... Class III Rising Pharma Holding, Inc.
Feb 1, 2024 HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit d... Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged... Class III Amerisource Health Services LLC
Jan 25, 2024 Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distribut... CGMP Deviations Class II Amerisource Health Services LLC
Jan 11, 2024 Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx... Failed Impurities/Degradation Specification. Class II Amerisource Health Services LLC
Dec 26, 2023 Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose c... Superpotent drug: Assay results were slightly above specification at the time zero point. Class III Amerisource Health Services LLC
Sep 1, 2023 HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per cart... Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged prod... Class III Amerisource Health Services LLC
Jun 23, 2023 Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister... Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. ... Class II Amerisource Health Services LLC
Mar 16, 2023 Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (1... Failed Dissolution Specifications: Out of specification dissolution results above specified values. Class II Amerisource Health Services LLC
Jan 27, 2023 Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 T... Failed Dissolution Specification: Out of specification dissolution results at time point zero. Th... Class II Amerisource Health Services LLC
Dec 27, 2022 BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton,... Failed Impurities/Degradation Specifications Class II Amerisource Health Services LLC
Dec 20, 2022 Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Di... Failed Impurities/Degradations Specifications Class II Amerisource Health Services LLC
May 3, 2022 Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsule... Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at... Class III American Health Packaging
Apr 12, 2022 Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutan... Subpotent Drug: Out of specification for assay. Class III American Health Packaging
Feb 22, 2022 Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL p... Impurity failure at 0-time of the repackaged lot. Class II American Health Packaging
Dec 20, 2021 Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, R... Failed Dissolution Specifications Class II American Health Packaging
Sep 17, 2021 GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each ... Failed Dissolution Specifications: results were above specification. Class II American Health Packaging
Sep 15, 2021 Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per ... CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contamin... Class II American Health Packaging
May 12, 2021 Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only,... Failed Impurities/Degradation Specifications Class III American Health Packaging
Jan 7, 2021 Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per cart... Failed Dissolution Specifications Class II American Health Packaging
Jun 10, 2020 Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blis... Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medi... Class III American Health Packaging
May 19, 2020 Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx ... Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month tim... Class II American Health Packaging
Feb 7, 2020 Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister ca... GMP Deviations: Product bottle may be absent of desiccant. Class II American Health Packaging
Feb 7, 2020 Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister ca... GMP Deviations: Product bottle may be absent of desiccant. Class II American Health Packaging
Dec 4, 2019 Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister card... Failed Dissolution Specifications: Low out of specification results obtained during stability tes... Class II American Health Packaging
Nov 20, 2019 Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), ... CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the ... Class II American Health Packaging
Nov 1, 2019 Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per c... CGMP Deviations: Presence of NDMA impurity detected in product. Class II American Health Packaging
Aug 27, 2019 Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, N... Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths secti... Class III American Health Packaging
Aug 9, 2019 Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister c... Failed Dissolution Specifications Class II American Health Packaging
May 13, 2019 Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only,... GMP Deviations; possible cross contamination of product due to cleaning procedure failure. Class II American Health Packaging
May 13, 2019 Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per bliste... GMP Deviations; possible cross contamination of product due to cleaning procedure failure. Class II American Health Packaging
May 13, 2019 Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per bliste... GMP Deviations; possible cross contamination of product due to cleaning procedure failure. Class II American Health Packaging
May 13, 2019 Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blis... GMP Deviations; possible cross contamination of product due to cleaning procedure failure. Class II American Health Packaging

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.