Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, In...
FDA Recall #D-0590-2025 — Class II — August 4, 2025
Product Description
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.
Recalling Firm
PFIZER INC — New York, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
49,620 vials
Distribution
U.S. Nationwide
Code Information
Lot #: LY3681, LY4360, LY4416, Exp. 02/28/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated