Fresenius Kabi Usa, Llc: Epinephrine Injection, Usp, 1mg/ml

Epinephrine Injection Recall Summary Fresenius Kabi is recalling Epinephrine Injection, USP, 1mg/mL in 1 mL single-dose vials nationwide because the product failed to meet impurities and degradation specifications. The affected vials have NDC numbers 63323-696-02 and 63323-696-25. This recall affects all U.S. states and territories.

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
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/a089e1eb-9efb-4cab-9b59-209638690380