Class III

Drug Recall: 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)

Fresenius Kabi USA, LLC · May 14, 2026

Reason for Recall

Failed Impurities/Degradations Specifications

Distribution

US Nationwide.

States Affected

NATIONWIDE

Quantity Affected

898,050 vials

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0581-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Fresenius Kabi USA, LLC Drug Recall: 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) | SafeCheck