Why it was recalled
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
Product description
Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY 11967. NDC 0517-3030-01
Lot numbers, UPCs & expiration codes
Lots: 25128L1C0, Exp. August 31, 2026; 25280L1C0, Exp. October 31, 2026; 26108L1C0, Exp. July 31, 2027
Where it was sold
Nationwide within the U.S.A
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-0865-2026
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Aug 11, 2026
- FDA report date
- Sep 16, 2026
- Quantity
- 31,935 30mL-vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Regent, Inc.
Original FDA data
Every field from FDA enforcement report D-0865-2026, exactly as published.
Show all FDA fields
- City
- Shirley
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 99670
- Address
- 5 Ramsay Rd
- Code information
- Lots: 25128L1C0, Exp. August 31, 2026; 25280L1C0, Exp. October 31, 2026; 26108L1C0, Exp. July 31, 2027
- Postal code
- 11967-4701
- Report date
- Sep 16, 2026
- Product type
- Drugs
- Recall number
- D-0865-2026
- Classification
- Class I
- Recalling firm
- American Regent, Inc.
- Product quantity
- 31,935 30mL-vials
- Reason for recall
- Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY 11967. NDC 0517-3030-01
- Distribution pattern
- Nationwide within the U.S.A
- Recall initiation date
- Aug 11, 2026
- Initial firm notification
- Letter
- Center classification date
- Sep 22, 2026