Browse Drug Recalls

392 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 392 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 392 FDA drug recalls.

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DateProductReasonClassFirm
Feb 4, 2021 Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wi... Failed Dissolution Specifications Class II Wilshire Pharmaceuticals Inc
Feb 4, 2021 Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: ... Failed Dissolution Specifications Class II Wilshire Pharmaceuticals Inc
Jan 29, 2021 Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manuf... Failed Dissolution Specifications Class III Akebia Therapeutics dba Keryx Biopharmaceutials...
Jan 7, 2021 Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per cart... Failed Dissolution Specifications Class II American Health Packaging
Dec 9, 2020 Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a... Failed dissolution specifications: out-of-specification test results observed during the buffer s... Class II Biogen MA Inc.
Dec 3, 2020 Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablet... Failed Dissolution Specifications Class II Zydus Pharmaceuticals (USA) Inc
Dec 3, 2020 Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets... Failed Dissolution Specifications Class II Zydus Pharmaceuticals (USA) Inc
Nov 25, 2020 Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India f... Failed Dissolution Specifications Class I Torrent Pharma Inc
Nov 24, 2020 Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by... Failed Dissolution Specifications; Out of Specification (low) results were obtained. Class II Ascend Laboratories LLC
Nov 18, 2020 Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, M... Failed Dissolution Specifications: Out of specification for dissolution. Class II The Harvard Drug Group
Nov 17, 2020 ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, M... FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits f... Class II Golden State Medical Supply Inc.
Nov 11, 2020 Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, ND... Failed Dissolution Specifications: Out of specification for dissolution. Class II Apotex Corp.
Oct 30, 2020 Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bo... Failed Dissolution Specifications Class II AVKARE Inc.
Oct 28, 2020 Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx ... Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during ... Class II Teva Pharmaceuticals USA
Oct 27, 2020 Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count c... Failed Dissolution Specification Class II Zydus Pharmaceuticals (USA) Inc
Oct 27, 2020 Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count c... Failed Dissolution Specification Class II Zydus Pharmaceuticals (USA) 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.
Aug 24, 2020 Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (6... Failed Dissolution Specifications Class II Strides Inc.
Jun 29, 2020 Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repacka... FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained dur... Class II RemedyRepack Inc.
May 27, 2020 Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 ... Failed Dissolution Specifications Class III Pfizer Inc.
May 22, 2020 Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose carto... Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf l... Class II The Harvard Drug Group
May 19, 2020 Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx ... Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month tim... Class II American Health Packaging
May 15, 2020 Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC ... Failed dissolution specifications Class II PD-Rx Pharmaceuticals, Inc.
May 13, 2020 Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC ... Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf l... Class II West-Ward Columbus Inc
May 11, 2020 Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, M... Failed Dissolution Specifications Class II Torrent Pharma Inc.
Apr 24, 2020 Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per un... Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine st... Class III The Harvard Drug Group
Mar 23, 2020 Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactu... Failed Dissolution Specifications: Out of specification result during long term testing in Tetrac... Class I Avet Pharmaceuticals, Inc.
Mar 23, 2020 Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactu... Failed Dissolution Specifications: Out of specification result during long term testing in Tetrac... Class I Avet Pharmaceuticals, Inc.
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

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.