FDA-Drug2026-04-15Class IIPROCESSING DEFECT
Fresenius Kabi 5% Dextrose Injection recalled for sterility concerns
OTHERNationwide distribution
Do not use Fresenius Kabi dextrose injection
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.
Hazard
Lack of Assurance of Sterility
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 USA, LLC recalls
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility assurance
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility assurance
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility concerns
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for lack of sterility assurance
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility assurance
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