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Browse Drug Recalls

14 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14 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 14 FDA drug recalls.

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DateProductReasonClassFirm
Oct 9, 2015 Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH... Presence of foreign substance -This recall has been intiated due to the presence of a polyethylen... Class II Mutual Pharmaceutical Company, Inc.
Jul 16, 2015 Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutua... Chemical Contamination; benzophenone leached from the product label varnish Class III Mutual Pharmaceutical Company, Inc.
Jul 16, 2015 Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmac... Chemical Contamination; benzophenone leached from the product label varnish Class III Mutual Pharmaceutical Company, Inc.
Jul 16, 2015 Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmac... Chemical Contamination; benzophenone leached from the product label varnish Class III Mutual Pharmaceutical Company, Inc.
Jul 16, 2015 Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutu... Chemical Contamination; benzophenone leached from the product label varnish Class III Mutual Pharmaceutical Company, Inc.
Jul 16, 2015 Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutua... Chemical Contamination; benzophenone leached from the product label varnish Class III Mutual Pharmaceutical Company, Inc.
Jul 16, 2015 Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutu... Chemical Contamination; benzophenone leached from the product label varnish Class III Mutual Pharmaceutical Company, Inc.
Jul 9, 2015 Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 5... cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product... Class II Mutual Pharmaceutical Company, Inc.
Jul 9, 2015 Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 5... cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product... Class II Mutual Pharmaceutical Company, Inc.
Jul 9, 2015 Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only... cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product... Class II Mutual Pharmaceutical Company, Inc.
Mar 10, 2015 Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by... Failed Impurities/Degradation Specifications: during long-term stability testing. Class II Mutual Pharmaceutical Company, Inc.
Feb 27, 2013 Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mu... Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in ... Class III Mutual Pharmaceutical Company, Inc.
Feb 27, 2013 FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102... Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in ... Class III Mutual Pharmaceutical Company, Inc.
Feb 27, 2013 Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 5... Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in ... Class III Mutual Pharmaceutical Company, 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.