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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.