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Browse Drug Recalls

1,309 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,309 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 1,309 FDA drug recalls in 2014.

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DateProductReasonClassFirm
Jan 9, 2014 ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc.... Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... Class I Schindele Enterprises dba Midwest Wholesale
Jan 9, 2014 BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also ... Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... Class I Schindele Enterprises dba Midwest Wholesale
Jan 9, 2014 XZEN PLATINUM, 750 mg, Distributed by: XZEN, Los Angeles, CA. Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... Class I Schindele Enterprises dba Midwest Wholesale
Jan 9, 2014 Magic For Men, packaged in 1ct blister pack and 12-pill/bottle, 390 mg Manuf... Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... Class I Schindele Enterprises dba Midwest Wholesale
Jan 9, 2014 Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Mainten... Lack of Assurance of Sterility; potential leakage from administrative port. Class II Hospira Inc.
Jan 9, 2014 MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Po... Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, a... Class I Schindele Enterprises dba Midwest Wholesale
Jan 9, 2014 Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in... Lack of Assurance of Sterility; potential leakage from administrative port. Class II Hospira Inc.
Jan 3, 2014 a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 1... Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count... Class II Dr. Reddy's Laboratories, Inc.
Jan 2, 2014 Zithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I.... Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of spec... Class III Pfizer Inc.

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.