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Browse Drug Recalls

104 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 104 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 104 FDA drug recalls.

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DateProductReasonClassFirm
Jan 18, 2016 Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrig... Labeling: label error on declared strength. Class II Perrigo Company PLC
Jan 8, 2016 Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged w... Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorre... Class II Perrigo Company PLC
Jan 8, 2016 Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HB... Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorre... Class II Perrigo Company PLC
Sep 28, 2015 Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter un... Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester Class III Perrigo Company PLC

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.