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Browse Drug Recalls

55 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 55 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 55 FDA drug recalls.

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DateProductReasonClassFirm
Mar 7, 2022 Procaine HCL 2% (20mg/mL), 30 ml-vial, Refrigerate, Tailor Made Compounding Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made ... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tai... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refriger... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Sep 28, 2018 Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Su... Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration dat... Class II Tailor Made Compounding

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.