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.

Clear
DateProductReasonClassFirm
Nov 14, 2014 Ticarcillin Sodium/Potassium Clavulanate (30:1) active pharmaceutical ingredi... Stability Data Does Not Support Expiry: All lots of all products repackaged and distributed betwe... Class II Attix Pharmaceuticals
Nov 14, 2014 Piperacillin Sodium active pharmaceutical ingredient packaged in varying gram... Stability Data Does Not Support Expiry: All lots of all products repackaged and distributed betwe... Class II Attix Pharmaceuticals
Oct 22, 2014 Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) ... Failed Dissolution Specifications: Product found to be out of specification (OOS) during stabilit... Class II Prometheus Laboratories Inc.
Oct 16, 2014 Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, R... Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified im... Class II Pharmaceutical Associates Inc
Oct 10, 2014 MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and D... Subpotent; 6 month stability time point Class III American Health Packaging
Oct 9, 2014 GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 50... Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification res... Class II Micro Labs Usa, Inc ...
Oct 2, 2014 Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, M... Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 ... Class III Valeant Pharmaceuticals International
Oct 2, 2014 VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-co... Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point. Class II West-Ward Pharmaceutical Corp.
Oct 2, 2014 candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactur... Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated ... Class III Sandoz, Inc
Oct 2, 2014 Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufacture... Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 ... Class III Valeant Pharmaceuticals International
Sep 26, 2014 Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles... Failed Dissolution Specifications; 12 month stability time point Class II Sun Pharma Global Inc.
Sep 26, 2014 Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/cart... Failed Dissolution Specification; at the 6-month stability time point Class II Forest Pharmaceuticals Inc
Sep 18, 2014 E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -c... Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months. Class III Bracco Diagnostic Inc
Sep 15, 2014 Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured ... Failed Dissolution Specifications: The product did not meet the acceptance criteria for the disso... Class II Astellas Pharma US Inc
Sep 11, 2014 MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21)... Subpotent; 6 month stability time point Class III Qualitest Pharmaceuticals
Sep 9, 2014 Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuj... Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine... Class II Hospira Inc.
Aug 28, 2014 FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalm... Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet t... Class II Fougera Pharmaceuticals Inc.
Aug 5, 2014 Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass... Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl im... Class III Akorn, Inc.
Jul 30, 2014 Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL... Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval a... Class III Pfizer Inc.
Jul 28, 2014 OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx onl... Failed Stability Specifications: Out of specification result for preservative sodium benzoate. Class III Boehringer Ingelheim Roxane Inc
Jul 11, 2014 Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (... Failed Dissolution Specifications: Product found to be out of specification (OOS) during stabilit... Class III Sandoz Inc
Jul 3, 2014 Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules... Failed Impurities/Degradation Specifications: High out-of-specification results for a related com... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Jul 2, 2014 E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manu... Subpotent Drug: Low out of specification results for both pH and assay obtained during routine st... Class III Bracco Diagnostic Inc
Jun 20, 2014 Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint F... Failed Impurity/Degradation Specification; 12-month stability time point Class III Novel Laboratories, Inc.
Jun 19, 2014 Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx on... Failed Impurities/Degradation Specifications: High out-of-specification results for a related com... Class III Mylan Pharmaceuticals Inc.
Jun 12, 2014 Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged... Failed Dissolution Specifications: Stability results found the product did not meet the drug diss... Class II Caraco Pharmaceutical Laboratories, Ltd.
Jun 6, 2014 DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorop... Stability Data Does Not Support Expiry Class III Estee Lauder Inc
May 28, 2014 Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule... Failed Stability Specification; out of specification result for particle size distribution during... Class III Novartis Pharmaceuticals Corp.
May 20, 2014 Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, ND... Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month ti... Class II West-Ward Pharmaceutical Corp.
May 1, 2014 Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories,... Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at... Class II Boehringer Ingelheim Roxane Inc
May 1, 2014 Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Ba... Failed Impurities/Degradation Specifications: this product is being recalled due to an out of spe... Class II Teva Pharmaceuticals USA
Apr 17, 2014 Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-... Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long te... Class III Wockhardt Usa Inc.
Apr 7, 2014 BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx on... Failed Impurities/Degradation Specifications: High out of specification impurity test results wer... Class II Teva Pharmaceuticals USA
Apr 7, 2014 BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx on... Failed Impurities/Degradation Specifications: High out of specification impurity test results wer... Class II Teva Pharmaceuticals USA
Apr 1, 2014 triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP... Failed Impurities/Degradation Specifications: This recall is due to out of specification for impu... Class II Teva Pharmaceuticals USA
Apr 1, 2014 Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 F... Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone... Class III Genesis Pharmaceutical, Inc.
Apr 1, 2014 HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (4... Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown... Class II Hi-Tech Pharmacal Co., Inc.
Mar 20, 2014 Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 3... Failed Dissolution Specifications: Stability results found the product did not meet the drug rele... Class II Caraco Pharmaceutical Laboratories, Ltd.
Mar 20, 2014 Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30... Failed Dissolution Specifications: Stability results found the product did not meet the drug rele... Class II Caraco Pharmaceutical Laboratories, Ltd.
Mar 20, 2014 Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Ap... Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 mont... Class III Apotex Inc.
Feb 11, 2014 QVAR¿ (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cy... Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point Class III Teva Pharmaceuticals USA
Feb 10, 2014 Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial, Rx... Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than No... Class III Pinnacle Biologics Inc
Jan 27, 2014 Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstit... Failed Impurities/Degradation Specifications: Product did not meet specification in total impurit... Class III Lupin Pharmaceuticals Inc.
Jan 27, 2014 Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstitute... Failed Impurities/Degradation Specifications: Product did not meet specification in total impurit... Class III Lupin Pharmaceuticals Inc.
Jan 14, 2014 Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distri... Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets,... Class II Mylan Pharmaceuticals Inc.
Jan 3, 2014 a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 1... Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count... Class II Dr. Reddy's Laboratories, Inc.
Dec 20, 2013 Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-c... Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples. Class II Watson Laboratories, Inc.-(Actavis) - Florida
Dec 16, 2013 VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx On... Failed Stability Testing: This product is below specification for preservative content. Class III Bracco Diagnostics Inc
Dec 13, 2013 Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tabl... Failed Dissolution Specification; 12-Month stability interval. Class II Dr. Reddy's Laboratories, Inc.
Dec 13, 2013 Pyridostigmine Bromide Tablets USP, 60 mg, 100 count bottle, Rx only, Manufac... Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP... Class II Corepharma LLC

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.