International Medication Systems Ltd.: Epinephrine Injection, Usp, 1 Mg/10ml (0.1 Mg/ml)
Recall Summary International Medication Systems Ltd. is recalling epinephrine injection (1 mg/10mL vials) distributed nationwide because the company cannot guarantee the product is sterile. This is a prescription medication used for emergency treatment of severe allergic reactions and other conditions. The recall affects batches distributed across all U.S. states.
- Recalling firm
- International Medication Systems Ltd.
- Product
- EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1
- Reason
- Lack of Assurance of Sterility
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-01
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S. Nationwide
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/c9a6a389-eb64-49e4-bd1a-0f08565fca74