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Browse Drug Recalls

4 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 4 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 4 FDA drug recalls.

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DateProductReasonClassFirm
Aug 24, 2024 AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed b... Discoloration Class III Rubicon Research Private Limited
May 6, 2024 Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distribute... Presence of Foreign Substance: metal in tablet Class II Rubicon Research Private Limited
Apr 26, 2024 traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distri... Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count t... Class II Rubicon Research Private Limited
Dec 31, 2021 Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distrib... Complaint received of foreign matter (metal) embedded in tablet. Class II Rubicon Research Private Limited

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.