Why it was recalled
Lack of Assurance of Sterility.
Product description
Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10.
Lot numbers, UPCs & expiration codes
Lot #: LY3681, LY4360, LY4416, Exp. 02/28/2026
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-0590-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 4, 2025
- FDA report date
- Aug 27, 2025
- Quantity
- 49,620 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PFIZER INC
Original FDA data
Every field from FDA enforcement report D-0590-2025, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 97364
- Address
- 68 Hudson Blvd E
- Code information
- Lot #: LY3681, LY4360, LY4416, Exp. 02/28/2026
- Postal code
- 10001-2188
- Report date
- Aug 27, 2025
- Product type
- Drugs
- Recall number
- D-0590-2025
- Classification
- Class II
- Recalling firm
- PFIZER INC
- Product quantity
- 49,620 vials
- Reason for recall
- Lack of Assurance of Sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Aug 4, 2025
- Initial firm notification
- Letter
- Center classification date
- Aug 18, 2025