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Browse Drug Recalls

5 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 5 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 5 FDA drug recalls.

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DateProductReasonClassFirm
Oct 21, 2025 Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (1... Lack of Assurance of Sterility. Class II Bristol-Myers Squibb Company
Jun 5, 2017 EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squ... Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eli... Class I Bristol-myers Squibb Company
Aug 29, 2012 BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactu... Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine v... Class I Bristol-myers Squibb Company
Jun 5, 2012 Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physi... Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly... Class II Bristol-myers Squibb Company
Jun 5, 2012 Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physi... Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly... Class II Bristol-myers Squibb Company

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.