Browse Drug Recalls

9 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 9 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 9 FDA drug recalls.

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DateProductReasonClassFirm
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
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 25, 2024 Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distr... Failed Dissolution Specifications Class II Amneal Pharmaceuticals of New York, 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.