Browse Drug Recalls

11 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 11 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 11 FDA drug recalls.

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DateProductReasonClassFirm
Jan 26, 2026 Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured ... Presence of Foreign Tablets/Capsules Class II Granules Pharmaceuticals Inc.
Aug 28, 2025 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Failed Impurities/Degradation Specifications: Class III Granules Pharmaceuticals Inc.
Aug 28, 2025 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Failed Impurities/Degradation Specifications: Class III Granules Pharmaceuticals Inc.
Aug 28, 2025 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Failed Impurities/Degradation Specifications: Class III Granules Pharmaceuticals Inc.
Aug 28, 2025 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Failed Impurities/Degradation Specifications: Class III Granules Pharmaceuticals Inc.
Aug 28, 2025 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Failed Impurities/Degradation Specifications: Class III Granules Pharmaceuticals Inc.
Jun 24, 2025 Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100... Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the ... Class II Granules Pharmaceuticals Inc.
Dec 30, 2024 Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bot... Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottl... Class II Granules Pharmaceuticals Inc.
Dec 18, 2024 Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granu... Failed Dissolution Specifications: Out of specification observed during the accelerated stability... Class II Granules Pharmaceuticals Inc.
Jul 31, 2024 Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by:... Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabap... Class II Granules Pharmaceuticals Inc.
Jul 3, 2020 Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bott... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Granules Pharmaceuticals Inc

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.