Browse Drug Recalls

412 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 412 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 412 FDA drug recalls.

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DateProductReasonClassFirm
Feb 20, 2020 Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only,... Failed Dissolution Specifications: Low out of specification dissolution result observed during st... Class II Teva Pharmaceuticals USA
Feb 12, 2020 Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, R... Failed Dissolution Specifications: Low out of specification results observed in dissolution test ... Class II Lupin Pharmaceuticals Inc.
Jan 22, 2020 Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bo... Failed Dissolution Specifications: low out of specification results for dissolution testing. Class III Ascend Laboratories LLC
Jan 20, 2020 Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufac... Failed Dissolution Specifications: testing revealed low out of specification result in one lot o... Class III Macleods Pharma Usa Inc
Dec 13, 2019 Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-coun... Failed Dissolution Specifications: High out of specification result observed at stability studies. Class III The Harvard Drug Group
Dec 10, 2019 Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-co... Failed Dissolution Specifications: High out of specification result observed at stability studies. Class III Lupin Pharmaceuticals Inc.
Dec 4, 2019 Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister card... Failed Dissolution Specifications: Low out of specification results obtained during stability tes... Class II American Health Packaging
Oct 18, 2019 Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Ph... Failed Dissolution Specification: Low out of specification dissolution results. Class II Mylan Pharmaceuticals Inc.
Aug 26, 2019 minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physici... Failed Dissolution Specifications: Class III EPI Health, LLC
Aug 9, 2019 Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister c... Failed Dissolution Specifications Class II American Health Packaging
Jul 29, 2019 Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured fo... Failed Dissolution Specifications Class II Upsher Smith Laboratories, Inc.
Jul 24, 2019 Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, ... Failed dissolution specifications Class II Alvogen, Inc
Jul 24, 2019 Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg... Failed dissolution specifications Class II Alvogen, Inc
Jul 19, 2019 Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b)... Failed Dissolution Specifications Class II Ascend Laboratories LLC
Jul 18, 2019 Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manu... Failed Dissolution Specifications. Class II Ucb, Inc
Jul 17, 2019 Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 333... Failed Dissolution Specifications Class II Macleods Pharma Usa Inc
Jul 9, 2019 Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into ... Failed dissolution specifications : failed results at the 3-month stability time point. Class I Jubilant Cadista Pharmaceuticals, Inc.
May 31, 2019 ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx o... Failed Dissolution Specifications: Out of specification result for dissolution. Class II Chiesi USA, Inc.
May 31, 2019 Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distri... Failed Dissolution Specifications: Out of specification result for dissolution. Class II Chiesi USA, Inc.
Apr 8, 2019 GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Pac... Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug r... Class II American Health Packaging
Mar 1, 2019 Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 4... Failed Dissolution Specifications Class III AVKARE Inc.
Feb 28, 2019 BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 coun... Failed Dissolution Specifications; 9-monthstability timepoint Class III Jubilant Cadista Pharmaceuticals, Inc.
Feb 22, 2019 Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, M... Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed du... Class II Ascend Laboratories LLC
Feb 21, 2019 Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only... Failed Dissolution Specifications Class III Lannett Company Inc.
Feb 19, 2019 Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05)... Failed dissolution specifications Class III Amerigen Pharmaceuticals Inc.
Jan 31, 2019 Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx ... Failed Dissolution Specifications: Out of specification results observed for high dissolution. Class II Dr. Reddy's Laboratories, Inc.
Jan 30, 2019 Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles... Failed Dissolution Specifications: high out of specification results for dissolution when measuri... Class III Valeant Pharmaceuticals North America LLC
Jan 30, 2019 Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles... Failed Dissolution Specifications: high out of specification results for dissolution when measuri... Class III Valeant Pharmaceuticals North America LLC
Jan 30, 2019 Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles... Failed Dissolution Specifications: high out of specification results for dissolution when measuri... Class III Valeant Pharmaceuticals North America LLC
Jan 30, 2019 Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured fo... Failed Dissolution Specifications: high out of specification results for dissolution when measuri... Class III Valeant Pharmaceuticals North America LLC
Jan 30, 2019 Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles... Failed Dissolution Specifications: high out of specification results for dissolution when measuri... Class III Valeant Pharmaceuticals North America LLC
Dec 20, 2018 Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and... Failed Dissolution Specifications Class III Amerigen Pharmaceuticals Inc.
Dec 20, 2018 Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, ... Failed Dissolution Specifications Class III Amerigen Pharmaceuticals Inc.
Dec 19, 2018 Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged i... Failed dissolution specifications Class II Teva Pharmaceuticals USA
Dec 14, 2018 Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufa... Failed Dissolution Specifications. Class II Cipla Limited
Dec 10, 2018 Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx... Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification ... Class II Dr. Reddy's Laboratories, Inc.
Nov 7, 2018 Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx... Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 1... Class II Dr. Reddy's Laboratories, 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.
Oct 19, 2018 Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, R... Failed dissolution specifications: Out-of-Specification dissolution test result obtained during r... Class II Teva Pharmaceuticals USA
Oct 5, 2018 Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05)... Failed dissolution specifications: Out-of-Specification dissolution results obtained during stabi... Class III Amerigen Pharmaceuticals Inc.
Sep 11, 2018 Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx ... Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at th... Class II Torrent Pharma Inc.
Aug 7, 2018 Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 5... Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged l... Class II PD-Rx Pharmaceuticals, Inc.
Aug 1, 2018 Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit ... Failed Dissolution Specifications: Out of specification result for the dissolution test. Class II American Health Packaging
Jul 30, 2018 Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit do... Failed Dissolution Specifications Class II MAJOR PHARMACEUTICALS
Jul 24, 2018 Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufact... Failed Dissolution Specifications: Class II West-Ward Columbus Inc
Jul 24, 2018 Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufac... Failed Dissolution Specifications: Class II West-Ward Columbus Inc
Apr 23, 2018 Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx on... Failed Dissolution Specifications. High dissolution results were obtained during stability testing. Class III Mckesson Packaging Services
Apr 23, 2018 Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx On... Failed Dissolution Specifications. High dissolution results were obtained during stability testing. Class III Mckesson Packaging Services
Apr 23, 2018 Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg,... Failed Dissolution Specifications. High dissolution results were obtained during stability testing. Class III Mckesson Packaging Services
Apr 17, 2018 Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-... Failed Dissolution Specification: Low dissolution outside of specifications Class III Rhodes Pharmaceuticals, L.P.

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.