Browse Drug Recalls
39 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 39 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 39 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 2, 2025 | Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 T... | Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product pack... | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Sep 2, 2025 | Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Ta... | Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product pack... | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Aug 20, 2025 | Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength ... | Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product pack... | Class II | Northwind Pharmaceuticals LLC |
| Aug 18, 2025 | chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, ... | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... | Class II | Amneal Pharmaceuticals, LLC |
| Aug 18, 2025 | Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, ... | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... | Class II | Amneal Pharmaceuticals, LLC |
| Aug 18, 2025 | chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only,... | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... | Class II | Amneal Pharmaceuticals, LLC |
| Aug 18, 2025 | chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only... | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... | Class II | Amneal Pharmaceuticals, LLC |
| Aug 18, 2025 | chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only,... | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... | Class II | Amneal Pharmaceuticals, LLC |
| Jun 2, 2025 | Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100... | Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial... | Class I | Amneal Pharmaceuticals, LLC |
| Apr 17, 2025 | Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), M... | Presence of Particulate Matter | Class I | Amneal Pharmaceuticals, 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 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 |
| Aug 1, 2024 | Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: ... | Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg with... | Class III | Amneal Pharmaceuticals, LLC |
| Mar 21, 2024 | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as... | Superpotent Drug: Due to overfilling of drug powder | Class I | Amneal Pharmaceuticals of New York, LLC |
| Feb 13, 2024 | Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottl... | Failed Impurities/Degradation Specifications: Out-of-specification test results. | Class II | Amneal Pharmaceuticals of New York, LLC |
| Jan 15, 2024 | Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only,... | Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. | Class II | Amneal Pharmaceuticals of New York, LLC |
| Dec 26, 2023 | Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets,... | Failed dissolution specifications | Class II | Amneal Pharmaceuticals of New York, LLC |
| Oct 27, 2023 | Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distribute... | Failed Dissolution Specifications | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 30, 2023 | Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bo... | Failed Dissolution Specifications: Out-of-specification results for dissolution (above specificat... | Class II | Amneal Pharmaceuticals of New York, LLC |
| Jul 11, 2022 | Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g... | Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Uns... | Class II | Tolmar, Inc. |
| Jan 26, 2022 | Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Ma... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, ... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amnea... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured ... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only,... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only,... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 coun... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 9... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 ta... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 ta... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distribut... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, ... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tabl... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only ... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| Oct 16, 2019 | Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10... | Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits. | Class III | Amneal Pharmaceuticals, Inc. |
| Aug 31, 2017 | Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Si... | Presence of Particulate Matter | Class II | Amneal Pharmaceuticals LLC |
| Dec 12, 2016 | Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65... | Failed Dissolution Specifications | Class II | Amneal Pharmaceuticals LLC |
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.