Browse Drug Recalls
16 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 16 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 16 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 7, 2015 | Nandrolone 200 mg/ml Injection, 10 mL and 20 mL vials, Rx, B & B Health Mart ... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PAPA/PGE1/PHENTO (30mg/50mcg/0.5mg/ml), Injection, 10 mL vial, Rx, B & B Heal... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PAPA/PGE1/PHENTO (35mg/12mcg/1.5mg/ml), Injection, 10 mL vial, Rx, B & B Heal... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PAPA/PGE1/PHENTO (30mg/40mcg/1mg/ml) Injection, 10 mL vial, Rx, B & B Health ... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B ... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B &... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | Stanozolol 200 mg/ml Injection, 20 mL vial, Rx, B & B Health Mart Pharmacy, B... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PAPA/PGE1/PHENTO (22.5mg/8.33mcg/0.833mg/ml) Injection, 10 mL vial, Rx, B & B... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PGE 20mcg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflowe... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | Testosterone Cypionate 250 mg/mL Injection, 10 mL vial, Rx, B & B Health Mart... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | Testosterone prop. 200 mg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pha... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PAPA/PHENTO (15mg/0.8333mg/ml) Injection, 5 mL vial, Rx, B & B Health Mart Ph... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PAPA/PHENTO (30mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health M... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PGE 25mcg/ml, Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflow... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PGE 30mcg/ml Injection, 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflow... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PAPA/PGE1/PHENTO (30mg/10mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & ... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
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.