FDA-Drug2026-04-15Class IIPROCESSING DEFECT
Fresenius Kabi 5% Dextrose Injection recalled for sterility concerns
What this means
Fresenius Kabi is recalling specific batches of 5% Dextrose Injection because the company cannot guarantee the product is sterile. This intravenous solution is used in hospitals and medical settings. The affected batches have expiration dates of February 28, 2027.
- If you work in a medical facility, check your inventory for batch numbers 6402399, 6402400, or 6402401.
- Do not use any units from these batches.
- Contact your supplier or Fresenius Kabi for instructions on returning or disposing of affected product.
- Contact your healthcare provider or hospital pharmacy if this product was already administered to you or a patient.
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
All ages
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 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-50.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0436-2026More Fresenius Kabi recalls
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- 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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