FDA recall D-0581-2026

Fresenius Kabi USA, LLC · Class III · drug

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 for recall

Failed Impurities/Degradations Specifications

Distribution

US Nationwide.

Key facts

Status: Ongoing
Initiation date: 2026-05-14
Report date: 2026-06-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0581-2026