Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Mar 22, 2018 Testosterone 100 mg pellet packaged in 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 MVI-7 (B1-100mg/B3-100mg, B5-252 mg, B6-102mg, Vit C-2500 mg, B12-10mg, Mag-1... 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 200 mg pellet packaged in 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 Naltrexone 200 mg pellet, 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 Vitamin D 50,000 unit/ml, 5 mL amber vial, Injectable Liquid, Rx only, Partel... 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 25 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 Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, 50 mL amber vial, Rx onl... 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 25 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 Biotin Suspension 10mg/mL, 5 mL 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 40 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/Finasteride 60 mg/5 mg pellet Amber vial, Rx only, Partell Speci... 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 #4 (ALP 20/PAPAV/PHENT 2), 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 Testosterone/Estradiol 60 mg/6 mg pellet 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 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 22, 2018 TM #1 (ALP 5.9/PAPAV 17.65/PHEN 0.59) Injectable solution, packaged in 3 mL a... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Nandrolone decanoate 200mg/mL, 5 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 22, 2018 Testosterone/Anastrozole 200 mg/20 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 Estradiol 12.5 mg (SD) pellets in amber vial, Rx only, Partell Specialty Phar... 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 (ALP 50/PAPAV 30/PHENT1.5 mg), 3 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/Finasteride 80 mg/8 mg pellet, amber vial, Rx only, Partell Spec... 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 35 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 55 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 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 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 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.

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.