Vial Label: 8 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: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 600…

Recall number

D-0591-2025

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: 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.