FDA-Drug2026-04-15Class IIPROCESSING DEFECT
Fresenius Kabi dextrose injection recalled for sterility concerns
What this means
Fresenius Kabi is recalling a specific batch of 5% Dextrose Injection due to lack of assurance of sterility. The affected product is in 50 mL freeflex bags. This intravenous medication was distributed nationwide, including Alaska and Puerto Rico.
- If you have Batch #6402296 with expiration date 07/31/2026 (NDC 65219-456-05 or 65219-456-60), stop use immediately
- Do not use the product for patient care
- Contact your pharmacy or healthcare provider if you have questions
- Notify Fresenius Kabi or the FDA if you have this batch
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
All ages (0 months and older)
Illnesses reported
None reported
Sold states
US Nationwide , Alaska, and Puerto Rico.
Manufactured in
3 Corporate Dr, Lake Zurich, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0435-2026More Fresenius Kabi recalls
- FDA-Drug2026-07-29Fresenius Kabi glycopyrrolate injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Naropin injection recalled for hair contamination
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