Fresenius Kabi USA, LLC recalls Epinephrine Injection
- Recalling company
- Fresenius Kabi USA, LLC
- Product
- 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)
- Reason
- Failed Impurities/Degradations Specifications
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- May 14, 2026
- Reported
- Jun 17, 2026
- Distribution
- US Nationwide.
- Status
- Ongoing
- Quantity
- 898,050 vials
- Lot / 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.
- Company location
- Lake Zurich, IL
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0581-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0581-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.