Browse Drug Recalls

17,897 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,897 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 17,897 FDA drug recalls.

DateProductReasonClassFirm
Mar 22, 2018 Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, packaged in a) 5 mL ambe... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Estradiol 10 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharm... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 TM #3 (ALP10/PAPAV12/PHENT1), 3 mL amber vial, Rx only, Partell Specialty Pha... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 HCG 1000 units/mL, packaged in a) 2 mL and b) 6 mL amber vial, Rx only, Parte... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone/Finasteride/Anastrozole 120 mg/10 mg/4 mg pellet Amber vial, Rx ... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Glutathione 200mg/mL, 10mL amber vial, Rx only, Partell Specialty Pharmacy, 5... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Lipoic Acid 25mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 58... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Methylcobalamin 12.5 mg/mL, Injectable Liquid, packaged in a) 5 mL amber vial... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone/Anastrozole 60 mg/4 mg pellets packaged in amber vial, Rx only, ... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone Cypionate 200mg/mL, 5 mL amber vial, Rx only, Partell Specialty ... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone 50 mg pellet packaged in amber vial, Rx only, Partell Specialt... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone 80 mg pellet packaged in amber vial, Rx only, Partell Specialt... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Progesterone 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pha... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Estradiol 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharma... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Estradiol 55 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharma... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone/Anastrozole 60 mg/1 mg pellets packaged in amber vial, Rx only, ... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone Propionate 100mg/mL, 5 mL amber vial, Rx only, Partell Special... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Pregnenolone 100 mg (SD) pellet, amber vial, Rx only, Partell Specialty Pharm... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone/Anastrozole 120 mg/8 mg pellets packaged in amber vial, Rx only,... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 TM #6 (ALP 25/PAPAV/PHENT1), 3 mL amber vial, Rx only, Partell Specialty Ph... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
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 19, 2018 Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0... Defective Container: This recall is being initiated due to product complaints regarding difficult... Class II Teva Pharmaceuticals USA
Mar 19, 2018 Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by:... Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One... Class III Glenmark Pharmaceuticals Inc., USA
Mar 19, 2018 Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Qual... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Lake Erie Medical & Surgical Supply 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 All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Co... Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange... Class I Bayer HealthCare 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 9, 2018 Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), pa... Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its lab... Class III Alva-Amco Pharmacal Companies., Inc.
Mar 9, 2018 Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by:... Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Class III Akorn, Inc.
Mar 8, 2018 Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pa... Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tada... Class I Jimmy Weber
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 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 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 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 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 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 5, 2018 Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd.... Failed impurities/degradation specifications: Failure to water content and impurity Class III InvaGen Pharmaceuticals, Inc.
Mar 5, 2018 methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Sin... Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Class II Sagent Pharmaceuticals Inc
Mar 5, 2018 methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Sin... Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Class II Sagent Pharmaceuticals Inc
Mar 5, 2018 Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johns... Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morph... Class II Johnson Matthey Inc.
Mar 5, 2018 Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded ... Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which con... Class III Pine Pharmaceuticals, LLC
Mar 5, 2018 Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5... Failed Impurities/Degradation Specifications Class III Novel Laboratories, Inc.
Mar 5, 2018 methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Sing... Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Class II Sagent Pharmaceuticals Inc
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 28, 2018 Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count... Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to ... Class III Osmotica Pharmaceutical Corp
Feb 26, 2018 Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.... Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in pr... Class II Paddock Laboratories, 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 23, 2018 Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured ... Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polym... Class III AstraZeneca Pharmaceuticals LP
Feb 23, 2018 Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%... Labeling: Label mix-up Class II Bayer HealthCare Pharmaceuticals, Inc.
Feb 22, 2018 labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Us... Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indica... Class III SCA Pharmaceuticals, 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.