Browse Drug Recalls
7 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 7 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 7 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 12, 2013 | Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 mL units, Not for Disp... | Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to ... | Class II | Zions RX Formulations Services LLC dba RX Formu... |
| Dec 12, 2013 | Oxytocin 30 Units in 500mL Sodium Chloride 0.9% Bags, Not for Dispensing, For... | Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to ... | Class II | Zions RX Formulations Services LLC dba RX Formu... |
| Dec 12, 2013 | Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, ... | Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination fo... | Class I | Zions RX Formulations Services LLC dba RX Formu... |
| Dec 12, 2013 | Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For ... | Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to ... | Class II | Zions RX Formulations Services LLC dba RX Formu... |
| Dec 12, 2013 | Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, Fo... | Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to ... | Class II | Zions RX Formulations Services LLC dba RX Formu... |
| Dec 12, 2013 | Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Ad... | Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to ... | Class II | Zions RX Formulations Services LLC dba RX Formu... |
| Dec 12, 2013 | Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration... | Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to ... | Class II | Zions RX Formulations Services LLC dba RX Formu... |
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.