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Browse Drug Recalls

167 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 167 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 167 FDA drug recalls.

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DateProductReasonClassFirm
May 6, 2015 Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)... Subpotent drug Class III Dr. Reddy's Laboratories, Inc.
May 6, 2015 Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bot... Subpotent drug Class III Dr. Reddy's Laboratories, Inc.
May 6, 2015 Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in ... Subpotent drug Class III Dr. Reddy's Laboratories, Inc.
May 6, 2015 Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a... Subpotent drug Class III Dr. Reddy's Laboratories, Inc.
Apr 24, 2015 Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Ma... Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. Class III Cipla Limited
May 23, 2014 Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-cou... Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point. Class II Dr. Reddy's Laboratories, Inc.
Jan 3, 2014 a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 1... Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count... Class II Dr. Reddy's Laboratories, Inc.
Dec 13, 2013 Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tabl... Failed Dissolution Specification; 12-Month stability interval. Class II Dr. Reddy's Laboratories, Inc.
Aug 29, 2013 IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05)... Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an inco... Class II Dr. Reddy's Laboratories, Inc.
Aug 2, 2013 Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum S... Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of... Class II Dr. Reddy's Laboratories, Inc.
Feb 15, 2013 Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) ... Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin ... Class II Dr Reddys Laboratories Tennessee LLC
Sep 27, 2012 Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd B... Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 mon... Class II Dr. Reddy's Laboratories, Inc.
Aug 1, 2012 Citalopram tablets USP, 20mg, 30-count bottle, Rx only, Manufactured by Dr. R... Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic... Class II Dr. Reddy's Laboratories, Inc.
Aug 1, 2012 Citalopram tablets USP, 10mg, 30-count bottle, Rx only, Manufactured by Dr. ... Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic... Class II Dr. Reddy's Laboratories, Inc.
Aug 1, 2012 Citalopram tablets USP, 40mg, 30-count bottle, Rx only, Manufactured by Dr. R... Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic... Class II Dr. Reddy's Laboratories, Inc.
Apr 9, 2012 Dr. Reddy's Ciprofloxacin Tablets, USP 500 mg*, 500 Tablets, Rx only, Mfd. By... Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of misl... Class II Dr. Reddy's Laboratories, Inc.
Apr 9, 2012 Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 50... Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of misl... Class II Dr. Reddy's Laboratories, 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.