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Browse Drug Recalls

17 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17 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 17 FDA drug recalls.

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DateProductReasonClassFirm
Mar 9, 2023 JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-01... Labeling: Label Mix-up Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Jan 26, 2022 Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 ... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
May 4, 2021 Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx... Subpotent Drug Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Mar 15, 2021 Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Oct 5, 2020 Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx... An extraneous peak was observed for dissolution testing. Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 5, 2020 Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx... An extraneous peak was observed for dissolution testing. Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 5, 2020 Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx... An extraneous peak was observed for dissolution testing. Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Mar 7, 2019 Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tabl... Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stabili... Class III Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 22, 2018 Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only,... Failed Dissolution Specifications: OOS resultsduring routine stability testing Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Sep 4, 2018 Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. R... Cross Contamination With Other Products: Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Dec 14, 2017 SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90... Failed Stability Specifications Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Sep 22, 2017 Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist.... Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incor... Class III Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 6, 2016 DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane ... Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 1... Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 6, 2016 Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dis... Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 1... Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Jul 24, 2015 COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 m... Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short tr... Class II Boehringer Ingelheim Roxane Inc
Nov 5, 2012 Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Di... Defective container; damaged bottles could allow moisture to get into the bottle and thus may imp... Class II Boehringer Ingelheim Roxane 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.