# FDA recall D-0433-2026

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

## Product

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10.

## Reason for recall

Lack of Assurance of Sterility

## Distribution

US Nationwide , Alaska, and Puerto Rico.

## Key facts

- **Recall number:** D-0433-2026
- **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-0433-2026

## Citation

> AI Analytics. FDA recall D-0433-2026. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0433-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*