# FDA recall D-0435-2026

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

## Product

5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60.

## Reason for recall

Lack of Assurance of Sterility

## Distribution

US Nationwide , Alaska, and Puerto Rico.

## Key facts

- **Recall number:** D-0435-2026
- **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-0435-2026

## Citation

> AI Analytics. FDA recall D-0435-2026. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0435-2026. Source: US FDA. Licensed CC0.

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