Browse Drug Recalls

114 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 114 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 114 FDA drug recalls.

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DateProductReasonClassFirm
Aug 21, 2013 buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count table... Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2... Class III Actavis South Atlantic LLC
Jul 31, 2013 BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count table... Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above appro... Class III Actavis Inc
Jun 3, 2013 Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54),... Failed Impurities/Degradation Specifications Class III Actavis
May 15, 2013 Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactu... Failed Impurity/Degradation Specification; "Related Compound C" Class II Actavis South Atlantic LLC
Mar 22, 2013 buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablet... Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour ... Class III Actavis South Atlantic LLC
Mar 22, 2013 Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-cou... Failed Tablet/Capsule Specifications: Broken tablets Class II Watson Laboratories, Inc.-(Actavis) - Florida
Mar 22, 2013 Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx onl... Failed Tablet/Capsule Specifications: Broken tablets Class II Actavis Inc
Feb 13, 2013 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceed... Class III Actavis Elizabeth LLC
Feb 4, 2013 buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carto... Failed Stability Specifications; out of specification results at the 9 month stability time point... Class III American Health Packaging
Jan 4, 2013 buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bot... Failed Dissolution Specifications; 8-hours for the 18-month stability testing point. Class III Actavis Pharmaceuticals
Aug 14, 2012 Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate... Impurities/Degradation Products: Recalled lots do not meet room temperature stability specificati... Class III Actavis Mid Atlantic LLC
Aug 14, 2012 Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phen... Impurities/Degradation Products: Recalled lots do not meet room temperature stability specificati... Class III Actavis Mid Atlantic LLC
Jul 23, 2012 Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , M... Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (A... Class III Stat Rx USA
Jul 11, 2012 Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 ... Subpotent; some patches may not contain fentanyl gel Class II Actavis

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.