Agency classClass IIOur severity:High FDA (Drugs)·D-0591-2025·Announced 2025-08-27

Sodium bicarbonate injection vials recalled for lack of assurance of sterility

Hospira 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL, lot LH2671, is recalled nationwide for lack of assurance of sterility. 15,750 vials are affected.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; loss of sterility assurance in an injectable medicine is a potential harm and no injuries are reported.

Plain-English summary

8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), from Hospira, Inc. of Lake Forest, Illinois, NDC 0409-6637-24 with case NDC 00409-6637-14, is being recalled. The prescription-only product is affected in lot LH2671 with an expiry of 11/30/2026. The recall covers 15,750 vials distributed nationwide.

The recall was issued for lack of assurance of sterility. The FDA classified the action as Class II.

Hospitals and pharmacies holding this lot should quarantine it, stop using it, and follow Hospira's instructions for return or replacement.

The recalled product

Product: SODIUM BICARBONATE (SODIUM BICARBONATE)
Brand: SODIUM BICARBONATE
Manufacturer: PFIZER INC
Category: Drug — Injectable
Hazard: sterility-assurance
injectable
class-ii
Affected units: 15,750

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot #: LH2671
Exp. 11/30/2026

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by PFIZER INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same brand · SODIUM BICARBONATE

High
Sodium bicarbonate injection recalled after arsenic exceeded impurity specification
FDA (Drugs) · 2025-09-17
High
Sodium Bicarbonate Injection Recalled Due to Sterility Assurance Issue
FDA (Drugs) · 2025-04-02
Severe
FDA Recalls Sodium Bicarbonate Injection Due to Glass Particle Contamination
FDA (Drugs) · 2024-01-24
Severe
FDA Recalls Sodium Bicarbonate Injection for Silicone Particulate Contamination
FDA (Drugs) · 2023-11-29
Severe
FDA Recalls Sodium Bicarbonate Injection for Defective Vials
FDA (Drugs) · 2022-12-21

Same manufacturer · PFIZER INC

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Same hazard · sterility assurance