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Browse Drug Recalls

105 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 105 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 105 FDA drug recalls.

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DateProductReasonClassFirm
Oct 9, 2015 Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH... Presence of foreign substance -This recall has been intiated due to the presence of a polyethylen... Class II Mutual Pharmaceutical Company, Inc.
Oct 1, 2015 Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fen... Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the... Class III Tribute Pharmaceuticals US Inc.
Mar 10, 2015 Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by... Failed Impurities/Degradation Specifications: during long-term stability testing. Class II Mutual Pharmaceutical Company, Inc.
May 21, 2013 Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count u... Crystallization; crystallized nimodipine Class II Sun Pharmaceutical Industries Inc.
Aug 21, 2012 Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count u... Crystallization: Presence of crystals of Nimodipine within the capsule solution. Class II Caraco Pharmaceutical Laboratories Ltd.

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.