Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Drug Recalls

66 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 66 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 66 FDA drug recalls.

Clear
DateProductReasonClassFirm
Nov 6, 2013 Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bot... Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content duri... Class III Sandoz Inc
Nov 6, 2013 Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only... Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which p... Class II GlaxoSmithKline, LLC.
Oct 22, 2013 Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured ... Cross Contamination with Other Products: findings of carryover of trace amounts of a previously m... Class II Sandoz Incorporated
Oct 11, 2013 Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 10... Subpotent; Hydrochlorothiazide at the 9 month time point. Class II Sandoz Inc
Oct 9, 2013 Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufac... Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended ... Class II Sandoz, Inc
Sep 25, 2013 Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bot... Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate T... Class III Sandoz Incorporated
Sep 23, 2013 Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for S... Subpotent Class III Tolmar, Inc.
Aug 7, 2013 Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 m... Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorg... Class III Sandoz Incorporated
Jun 21, 2013 Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, ... Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets. Class II Sandoz Incorporated
May 30, 2013 Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, si... Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, ... Class II Sandoz Incorporated
May 20, 2013 Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL S... Presence of Particulate Matter: Found during examination of retention samples. Class I Sandoz Incorporated
Apr 18, 2013 Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for S... Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 ... Class II Sandoz Incorporated
Jan 22, 2013 Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blist... Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debo... Class III Sandoz Incorporated
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
Sep 12, 2012 Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx... Impurities/Degradation Products: An out of specification result for a known impurity of the produ... Class III Sandoz Incorporated
Sep 12, 2012 Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, R... Impurities/Degradation Products: An out of specification result for a known impurity of the produ... Class III Sandoz Incorporated

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.