← FDA ENFORCEMENT
D-0591-2025Class II

PFIZER INC

Recalling firm
PFIZER INC
Product type
Drug
Status
Ongoing
Report date
2025-08-27
Distribution
U.S. Nationwide
Firm state
NY
Product quantity
15,750 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility.

Product description

Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14.

Code / lot info

Lot #: LH2671, Exp. 11/30/2026

Other recalls SPEQ maps to Environmental Monitoring
2026-07-22Class IIGELLERT GLOBAL GROUP2026-07-22Class IFrutas y Hortalizas del Sur S.A.2026-07-22Class IICareFusion 213, LLC2026-07-22Class IIChiesi USA, Inc.
See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. 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.