Why it was recalled
Lack of Assurance of Sterility
Product description
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
Lot numbers, UPCs & expiration codes
Lot Number: EA038A5, Expiration Date: 08/2026.
Where it was sold
U.S. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0483-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 1, 2026
- FDA report date
- Apr 22, 2026
- Quantity
- 81,520 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- International Medication Systems Ltd.
Original FDA data
Every field from FDA enforcement report D-0483-2026, exactly as published.
Show all FDA fields
- City
- South El Monte
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 98690
- Address
- 1886 Santa Anita Ave
- Code information
- Lot Number: EA038A5, Expiration Date: 08/2026.
- Postal code
- 91733-3414
- Report date
- Apr 22, 2026
- Product type
- Drugs
- Recall number
- D-0483-2026
- Classification
- Class II
- Recalling firm
- International Medication Systems Ltd.
- Product quantity
- 81,520 units
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Apr 1, 2026
- Initial firm notification
- Letter
- Center classification date
- Apr 14, 2026