Browse Drug Recalls

13 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 13 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 13 FDA drug recalls.

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DateProductReasonClassFirm
Jun 26, 2014 Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756... CGMP Deviations: These products are being recalled because they were manufactured with active pha... Class II Caraco Pharmaceutical Laboratories, Ltd.
Jun 26, 2014 Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756... CGMP Deviations: These products are being recalled because they were manufactured with active pha... Class II Caraco Pharmaceutical Laboratories, Ltd.
Jun 12, 2014 Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged... Failed Dissolution Specifications: Stability results found the product did not meet the drug diss... Class II Caraco Pharmaceutical Laboratories, Ltd.
Apr 9, 2014 Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, ... Lack of Assurance of Sterility: A particle excursion for a different batch of the same product ma... Class II Caraco Pharmaceutical Laboratories, Ltd.
Apr 9, 2014 Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle... Failed Impurities/Degradation Specifications: out of specification results for impurities/degrada... Class III Caraco Pharmaceutical Laboratories, Ltd.
Apr 9, 2014 Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufac... Failed Impurities/Degradation Specifications: out of specification results for impurities/degrada... Class III Caraco Pharmaceutical Laboratories, Ltd.
Mar 20, 2014 Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30... Failed Dissolution Specifications: Stability results found the product did not meet the drug rele... Class II Caraco Pharmaceutical Laboratories, Ltd.
Mar 20, 2014 Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 3... Failed Dissolution Specifications: Stability results found the product did not meet the drug rele... Class II Caraco Pharmaceutical Laboratories, Ltd.
Jan 29, 2014 Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: ... Failed Tablet Specifications: Broken Tablets Present. Class II Caraco Pharmaceutical Laboratories Ltd.
Jan 28, 2014 Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bott... Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of... Class II Caraco Pharmaceutical Laboratories, Ltd.
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.
Nov 5, 2012 traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Man... Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Trama... Class II Caraco Pharmaceutical Laboratories, Ltd.
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.