Vial Label: Epinephrine Injection recalled over sterility concerns

Recall date

August 4, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

PFIZER INC recalls Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60…

Recall number

D-0590-2025

FDA classification

Class II

Brand / firm

PFIZER INC

Sold / distributed

U.S. Nationwide

Why it was recalled

Lack of Assurance of Sterility.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.