FDA-Drug2026-04-15Class IIPROCESSING DEFECT
Fresenius Kabi 5% Dextrose Injection recalled for sterility concerns
What this means
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.
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 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 recalls
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