Browse Drug Recalls

15 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 15 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 15 FDA drug recalls.

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DateProductReasonClassFirm
Oct 6, 2016 NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and d... Presence of Foreign Tablets/Capsules Class III Actavis Elizabeth LLC
Jul 11, 2016 Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles... Failed Dissolution Specifications Class II Actavis Inc
Feb 16, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... Failed Impurities/Degradation Specifications: Out of specification for impurities. Class II Actavis Elizabeth LLC
Feb 16, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... Failed Impurities/Degradation Specifications: Out of specification for impurities. Class II Actavis Elizabeth LLC
Feb 16, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... Failed Impurities/Degradation Specifications: Out of specification for impurities. Class II Actavis Elizabeth LLC
Feb 16, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... Failed Impurities/Degradation Specifications: Out of specification for impurities. Class II Actavis Elizabeth LLC
Feb 10, 2015 Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles,... Failed Dissolution Specifications Class II Actavis Elizabeth LLC
Dec 15, 2014 Gabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45... Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and bre... Class II Actavis Elizabeth LLC
Dec 15, 2014 Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14... Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and bre... Class II Actavis Elizabeth LLC
Dec 15, 2014 Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactu... Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and bre... Class II Actavis Elizabeth LLC
Feb 10, 2014 Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured ... Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for... Class II Actavis Elizabeth LLC
Feb 4, 2014 Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, ... Failed Dissolution Specifications: Product did not meet specification requirements for dissolution. Class II Actavis Elizabeth LLC
Nov 6, 2013 Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth L... Subpotent Drug: During routine stability testing one tablet was found with tablet weight below sp... Class II Actavis Elizabeth LLC
Oct 9, 2013 Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Onl... Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below sp... Class II Actavis Elizabeth LLC
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

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.