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Browse Drug Recalls

116 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 116 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 116 FDA drug recalls.

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DateProductReasonClassFirm
Aug 16, 2017 Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz... Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contam... Class II Pharmatech LLC
Aug 2, 2017 Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (23... Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia conta... Class II The Harvard Drug Group
Jan 5, 2017 Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufa... Failed Dissolution Specifications Class II The Harvard Drug Group
Jan 5, 2017 Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufa... Failed Dissolution Specifications Class II The Harvard Drug Group
Dec 27, 2016 Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by ... Superpotent Drug; out of specification results for assay (manufacturer) Class III The Harvard Drug Group
Aug 8, 2016 Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: M... CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... Class II Pharmatech LLC
Jul 28, 2015 Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets ... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jun 10, 2015 OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manuf... Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 ... Class II The Harvard Drug Group, LLC
Jul 16, 2014 Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Ch... Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspens... Class II Bio-pharm, Inc.
Apr 10, 2014 Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube p... Crystallization: Crystal precipitate formation and an increase in the number of complaints associ... Class II Bausch & Lomb, Inc.
Apr 9, 2014 Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10)... Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Rele... Class II Legacy Pharmaceutical Packaging
Mar 27, 2013 Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceu... Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009 Class III Legacy Pharmaceutical Packaging LLC
Sep 20, 2012 Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manuf... Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacycl... Class III Sandoz Incorporated
Aug 17, 2012 Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by... Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide... Class III Axcentria Pharmaceuticals LLC
Jul 12, 2012 Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 m... Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packagi... Class III Axcentria Pharmaceuticals LLC
Sep 27, 2011 Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to conta... Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calc... Class II Shamrock Medical Solutions Group 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.