Fresenius Kabi Usa, Llc: Epinephrine Injection, Usp, 1mg/ml
Recall Summary Fresenius Kabi is recalling Epinephrine Injection, USP, 1mg/mL in single-dose vials nationwide because testing at 18 months showed the product failed to meet purity and degradation standards. The affected product has NDC numbers 63323-696-02 (vial) and 63323-696-25 (carton). This is a Class III recall affecting all U.S. states and Washington, D.C.
- Recalling firm
- 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; out-of-specification (OOS) results obtained at the 18-month stability test.
- Classification
- Class III
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-14
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/2eac88c3-a8b8-4e40-a754-fc8c9e96f253