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Browse Drug Recalls

12 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 12 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 12 FDA drug recalls.

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DateProductReasonClassFirm
Aug 5, 2016 Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 ... Failed Impurities/Degradation Specifications. Class III Teva North America
Jul 15, 2016 Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg p... Failed Content Uniformity Specifications: out of specification test result for spray content unif... Class III Teva North America
Jun 24, 2016 Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Man... Superpotent drug: Out of specification test result for assay during stability testing. Class II Teva North America
Jun 22, 2016 Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in ... Presence of Foreign Substance; presence of black particles describes generically as cellulose-bas... Class II Teva North America
Jun 17, 2016 Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hun... CGMP Deviations Class II Teva North America
Jun 17, 2016 Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intrave... CGMP Deviations Class II Teva North America
Jun 17, 2016 Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA P... CGMP Deviations Class II Teva North America
Jun 17, 2016 ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Onl... CGMP Deviations Class II Teva North America
May 31, 2016 mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multip... Failed Impurities/Degradation Specifications: High out of specification results for Impurity D. Class III Teva North America
May 18, 2016 Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles,... Failed Tablet/Capsule Specifications Class III Teva North America
Apr 27, 2016 Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-3... Lack of Assurance of Sterility: Due to potential for leaking bags. Class II Teva North America
Dec 21, 2015 Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bo... Failed Dissolution Specifications: low test results at the 18 month time-point Class II Teva North America

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.