Browse Drug Recalls

3,458 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,458 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 3,458 FDA drug recalls.

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DateProductReasonClassFirm
Jun 21, 2012 OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 6... CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation Class II Oklahoma Respiratory Care Inc
Jun 21, 2012 Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, ... CGMP Deviations: Shipment of product not approved for release. Class III Hospira, Inc.
May 25, 2012 Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 ... CGMP Deviations: This product is being recalled because expired flavoring was used in the manufac... Class II Mallinckrodt Inc.
May 14, 2012 Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial ... CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have app... Class II Abbott Laboratories
May 4, 2012 LifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration ... Class II Linde Gas LLC
Feb 6, 2012 Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for:... CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, w... Class II sanofi-aventis US, Inc.
Feb 6, 2012 Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. fo... CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, w... Class II sanofi-aventis US, Inc.
Jun 15, 2011 Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metere... CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product. Class III Apotex Corp.

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.