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