FDA-Drug2026-04-15Class IIPROCESSING DEFECT
Fresenius Kabi 5% Dextrose Injection recalled for sterility concerns
OTHERNationwide distribution
Stop using Fresenius Kabi dextrose injection
Fresenius Kabi USA is recalling a specific batch of 5% Dextrose Injection due to concerns that the product may not meet sterility standards. This injectable solution is used in medical settings to deliver fluids and glucose to patients. The affected batch (6402165, expiring 05/30/2028) was distributed nationwide.
- If you have this product in your facility or home, do not use it.
- Contact your healthcare provider, pharmacy, or Fresenius Kabi immediately if you have questions about whether you received this batch.
- Report any adverse effects to the FDA's MedWatch program at 1-888-SAFEMED.
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 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0437-2026More 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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