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Browse Drug Recalls

59 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 59 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 59 FDA drug recalls.

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DateProductReasonClassFirm
Dec 31, 2018 Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Auro... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Au... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Nov 30, 2018 Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bo... Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets f... Class III Aurobindo Pharma USA Inc.
Dec 22, 2016 Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottle... Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted caps... Class II Aurobindo Pharma USA Inc
Dec 16, 2016 Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only,... Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance. Class III Aurobindo Pharma USA Inc
Aug 3, 2016 Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets pe... Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of on... Class II Aurobindo Pharma USA Inc
Oct 17, 2014 Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for... Failed Tablet/Capsule Specifications: Complaints of empty capsules received. Class II Aurobindo Pharma USA Inc
Apr 9, 2013 Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufa... Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label Class III Aurobindo Pharma USA 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.