FDA recall D-0590-2025

PFIZER INC · Class II · drug

Product

Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10.

Reason for recall

Lack of Assurance of Sterility.

Distribution

U.S. Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-08-04
Report date: 2025-08-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0590-2025