# FDA recall D-0591-2025

> **PFIZER INC** · Class II · drug recall initiated 2025-08-04.

## 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.

## Reason for recall

Lack of Assurance of Sterility.

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-0591-2025
- **Recalling firm:** PFIZER INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-08-04
- **Report date:** 2025-08-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New York, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0591-2025

## Citation

> AI Analytics. FDA recall D-0591-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0591-2025. Source: US FDA. Licensed CC0.

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