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
Nov 12, 2021 Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Exten... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets U... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Exten... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoe... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablet... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Exte... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrin... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrin... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine H... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Oct 8, 2021 Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured fo... Out of specification result observed in a dissolution test at the 9-month long term stability tim... Class II Lupin Pharmaceuticals Inc.
Sep 27, 2021 Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets... Failed Dissolution Specifications Class II Strides Pharma Inc.
Sep 17, 2021 GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each ... Failed Dissolution Specifications: results were above specification. Class II American Health Packaging
Aug 23, 2021 Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx... Failed Dissolution Specifications Class II Viatris
Aug 6, 2021 Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx onl... Failed Dissolution Specifications Class II The Harvard Drug Group
Jul 29, 2021 Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, D... Failed Dissolution Specifications Class II The Harvard Drug Group
Jul 2, 2021 NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 cou... Failed Dissolution Specification: Out of specification for dissolution during routine stability t... Class II The Harvard Drug Group
Apr 1, 2021 Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Ju... Failed Dissolution Specifications Class II Jubilant Cadista Pharmaceuticals, Inc.
Mar 15, 2021 NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAP... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Feb 26, 2021 Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Di... Failed Dissolution Specifications: Out-of-specification results observed for dissolution during s... Class II Dr. Reddy's Laboratories, Inc.
Feb 17, 2021 Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-3... Failed Dissolution Specifications Class II Dr. Reddy's Laboratories, Inc.
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.

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.