# FDA recall D-0491-2025

> **B BRAUN MEDICAL INC** · Class II · drug recall initiated 2025-06-16.

## Product

0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.

## Reason for recall

Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0491-2025
- **Recalling firm:** B BRAUN MEDICAL INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-06-16
- **Report date:** 2025-07-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allentown, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0491-2025

## Citation

> AI Analytics. FDA recall D-0491-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0491-2025. Source: US FDA. Licensed CC0.

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