# FDA recall D-0424-2026

> **Fresenius Kabi USA, LLC** · Class II · drug recall initiated 2026-03-11.

## Product

0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).

## Reason for recall

Lack of Assurance of Sterility

## Distribution

US Nationwide , Alaska, and Puerto Rico.

## Key facts

- **Recall number:** D-0424-2026
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-03-11
- **Report date:** 2026-04-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Zurich, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0424-2026

## Citation

> AI Analytics. FDA recall D-0424-2026. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0424-2026. Source: US FDA. Licensed CC0.

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