← FDA ENFORCEMENT
D-0590-2025Class II

PFIZER INC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
PFIZER INC
Product type
Drug
Status
Ongoing
Report date
2025-08-27
Distribution
U.S. Nationwide
Firm state
NY
Product quantity
49,620 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility.

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.

Code / lot info

Lot #: LY3681, LY4360, LY4416, Exp. 02/28/2026

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →