PFIZER INC: Drug Recall

Recall #D-0591-2025 · 08/04/2025

Class II: Risk

Recall Details

Recall Number: D-0591-2025
Classification: Class II
Product Type: Drug
Recalling Firm: PFIZER INC
Status: Ongoing
Date Initiated: 08/04/2025
Location: New York, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 15,750 vials

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.

Distribution Pattern

U.S. Nationwide

Other Recalls by PFIZER INC

Class II: Risk 08/04/2025

Lack of Assurance of Sterility.
Class II: Risk 07/10/2025

CGMP Deviations; particulates identified during visual inspection
Class II: Risk 07/10/2025

CGMP Deviations; particulates identified during visual inspection
Class II: Risk 05/28/2025

Discoloration; discolored solution from cracked vials
Class II: Risk 05/20/2024

Lack of Assurance of Sterility-The potential for incomplete crimp seals.

View all recalls by PFIZER INC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.