FDA Drugs recall ·
Vial Label: 8.4% Sodium Bicarbonate Injection, USP… recall
- Recall number
- D-0591-2025
- Date
- (initiated August 4, 2025)
- Company / brand
- Pfizer Inc.
68 Hudson Blvd E, New York, NY, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 15,750 vials
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Lack of Assurance of Sterility.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: LH2671, Exp. 11/30/2026
Distribution
U.S. Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0591-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.