FDA-Drug2026-04-15Class IIPROCESSING DEFECT
Fresenius Kabi dextrose injection recalled for sterility concerns
OTHERNationwide distribution
Stop using Fresenius Kabi dextrose injection
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
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 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 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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