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Browse Drug Recalls

16 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 16 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 16 FDA drug recalls.

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DateProductReasonClassFirm
Apr 6, 2018 Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bott... Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisino... Class III Sandoz Incorporated
Jun 16, 2017 Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 07... Cross Contamination With Other Product: Imipramine Class III Sandoz Incorporated
Dec 22, 2016 Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactu... Failed dissolution specification: recalled due to an out of specification dissolution result of 4... Class II Sandoz Incorporated
Dec 5, 2014 Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sand... Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an i... Class III Sandoz Incorporated
Jul 25, 2014 Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeto... Presence of Foreign Substance; tablets may contain stainless steel metal particulates Class II Sandoz Incorporated
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
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
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.