Browse Drug Recalls
11 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 11 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 11 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 21, 2016 | Bimix 30 mg/1 mg/mL Injectable, a) 5 mL and b) 10 mL vial, Compounded by Well... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | Arginine/Citrulline/Ornit+Lido 100/100/100/10 mg/mL Injectable, 10 mL vials, ... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | Arginine HCl 100 mg/mL Injectable,10 mL, Compounded by Wells Pharmacy Network... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | B-complex + Vit C 20 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharma... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 19, 2016 | Testosterone 60 mg/Anastrazole 4 mg Pellet, Compounded by: Wells Pharmacy Net... | Superpotent and Subpotent drugs | Class II | Wells Pharmacy Network, LLC |
| Sep 19, 2016 | Estradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network | Superpotent and Subpotent drugs | Class III | Wells Pharmacy Network, LLC |
| Sep 19, 2016 | Estradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network | Superpotent and Subpotent drugs | Class III | Wells Pharmacy Network, LLC |
| Sep 19, 2016 | Testosterone 200 mg/Anastrazole 20mg Pellet, Compounded by: Wells Pharmacy Ne... | Superpotent and Subpotent drugs | Class II | Wells Pharmacy Network, LLC |
| Sep 19, 2016 | Testosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network | Superpotent and Subpotent drugs | Class III | Wells Pharmacy Network, LLC |
| Sep 19, 2016 | Testosterone Cholesterol ,100 mg Pellet, Compounded by: Wells Pharmacy Network | Superpotent and Subpotent drugs | Class III | Wells Pharmacy Network, LLC |
| Sep 19, 2016 | Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Ne... | Superpotent and Subpotent drugs | Class II | Wells Pharmacy Network, 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.