Browse Drug Recalls

1,020 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,020 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 1,020 FDA drug recalls.

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DateProductReasonClassFirm
Oct 19, 2018 children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, ... Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit wa... Class II Taro Pharmaceuticals U.S.A., Inc.
Oct 19, 2018 children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHIS... Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit wa... Class II Taro Pharmaceuticals U.S.A., Inc.
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.
Oct 5, 2018 Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured... Failed Impurities/Degradation Specifications:Out of specification result noticed for total impuri... Class II LUPIN SOMERSET
Oct 3, 2018 Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactu... Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 mo... Class III InvaGen Pharmaceuticals, Inc.
Sep 27, 2018 Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per... Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtaine... Class II Teva Pharmaceuticals USA
Sep 21, 2018 Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only,... Failed Disintegration Specifications: Out-of-specification disintegration test result obtained du... Class II Teva Pharmaceuticals USA
Sep 21, 2018 Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, ... Failed stability specifications - An out of specification result was observed for the test parame... Class II Dr. Reddy's Laboratories, Inc.
Sep 20, 2018 Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only... Failed Stability Specifications: Out-of-specification test result for water content obtained duri... Class II Teva Pharmaceuticals USA
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 28, 2018 Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx o... Failed Impurities/Degradation Specifications; Out of specification stability testing results at t... Class III Pfizer Inc.
Aug 27, 2018 MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubil... Failed Stability Specifications: An out-of-specification result was obtained during 18-month stab... Class III Jubilant Cadista Pharmaceuticals, Inc.
Aug 23, 2018 Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, ... Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being... Class III LUPIN SOMERSET
Aug 7, 2018 Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only... Failed Impurities/Degradation Specifications: Out of specification test results obtained during r... Class III Mylan Pharmaceuticals Inc.
Aug 7, 2018 Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only... Failed Impurities/Degradation Specifications: Out of specification test results obtained during r... Class III Mylan Pharmaceuticals Inc.
Aug 3, 2018 dr. brandt, BB cream with signature FLEXITONE, SPF 30, 1 oz./30 g tube, Distr... Failed Stability Specifications: separation of product and failure for actives. Class II Product Quest Manufacturing LLC
Aug 2, 2018 Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. R... Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Tot... Class III Dr. Reddy's Laboratories, Inc.
Aug 1, 2018 Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by... Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impuri... Class II Akorn, Inc.
Jul 26, 2018 Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactur... Failed Impurities/Degradation Specifications: An out-of-specification result in the related subst... Class III Lupin Pharmaceuticals Inc.
Jul 11, 2018 Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 10... Failed Stability Specifications: lot out of specification for elevated water vapor. Class III Renaissance Lakewood, LLC
Jul 11, 2018 Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 20... Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodiu... Class III Renaissance Lakewood, LLC
Jun 29, 2018 Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic ... Subpotent Drug: Stability data does not support the current expiration dating of 55 days after co... Class II SCA Pharmaceuticals
Jun 27, 2018 Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Ph... Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... Class III Aidarex Pharmaceuticals LLC
Jun 27, 2018 Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex ... Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... Class III Aidarex Pharmaceuticals LLC
Jun 27, 2018 Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Ph... Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... Class III Aidarex Pharmaceuticals LLC
Jun 22, 2018 eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hy... Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity Class II Eb5 Corporation
Jun 15, 2018 Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ra... Subpotency: lower than expected potency result was obtained at the 18 month stability time point. Class III Validus Pharmaceuticals, Inc.
Jun 15, 2018 Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distri... Subpotency: lower than expected potency result was obtained at the 18 month stability time point. Class III Validus Pharmaceuticals, Inc.
Jun 7, 2018 Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 m... Superpotent Drug: Composite assay results obtained during routine stability testing were slightly... Class III Mylan Pharmaceuticals Inc.
May 7, 2018 Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perr... Failed Stability Specifications Class II Perrigo New York
Apr 30, 2018 Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 pa... Failed Stability Specifications Class III Teva Pharmaceuticals USA
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 13, 2018 OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box ... Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS... Class III Septodont Inc.
Apr 10, 2018 Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 co... Failed Stability Specifications Class II Pharmalucence, Inc.
Mar 21, 2018 Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne... Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability... Class III Mayne Pharma Inc
Mar 15, 2018 buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles,... Failed Dissolution Specifications; during stability testing Class III InvaGen Pharmaceuticals, Inc.
Mar 15, 2018 buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC ... Failed Dissolution Specifications; during stability testing Class III InvaGen Pharmaceuticals, Inc.
Mar 8, 2018 E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Ma... Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - met... Class II Bracco Diagnostics Inc.
Mar 8, 2018 Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr.... Failed Stability Specifications:Out-of-specification results observed for viscosity during stabil... Class III Dr. Reddy's Laboratories, Inc.
Mar 7, 2018 Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (... Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expirat... Class II American Pharmaceutical Ingredients LLC
Mar 7, 2018 Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOc... Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is ... Class II Apollo Care
Mar 7, 2018 Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC... Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expirat... Class II American Pharmaceutical Ingredients LLC
Mar 7, 2018 Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag, Rx only, APO... Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is ... Class II Apollo Care
Mar 2, 2018 Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flex... Superpotent and Failed Stability Specifications; out of specification results for assay and water... Class III Renaissance Lakewood, LLC
Feb 26, 2018 RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured ... Failed Stability Specifications Class II Mckesson Packaging Services
Feb 21, 2018 Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Onl... Failed Stability Specification: OOS low viscosity results discovered during retain testing. Class III Akorn, Inc.
Feb 19, 2018 Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufact... cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II Kalchem International, Inc.
Feb 15, 2018 Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOL... Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is ... Class II Apollo Care

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.