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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.