Why it was recalled
Failed Impurities/Degradations Specifications
Product description
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)
Lot numbers, UPCs & expiration codes
Batch # 6133313, 6133314, Exp Date: 06/2026; Batch # 6133315, Exp Date: 07/2026; Batch # 6133682, Exp Date: 09/2026; Batch # 6134812, 6134813, Exp Date: 04/2027.
Where it was sold
US 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-0581-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- May 14, 2026
- FDA report date
- Jun 17, 2026
- Quantity
- 898,050 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-0581-2026, exactly as published.
Show all FDA fields
- City
- Lake Zurich
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 98997
- Address
- 3 Corporate Dr
- Code information
- Batch # 6133313, 6133314, Exp Date: 06/2026; Batch # 6133315, Exp Date: 07/2026; Batch # 6133682, Exp Date: 09/2026; Batch # 6134812, 6134813, Exp Date: 04/2027.
- Postal code
- 60047-8930
- Report date
- Jun 17, 2026
- Product type
- Drugs
- Recall number
- D-0581-2026
- Classification
- Class III
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 898,050 vials
- Reason for recall
- Failed Impurities/Degradations Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)
- Distribution pattern
- US Nationwide.
- Recall initiation date
- May 14, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 5, 2026