Fresenius Kabi USA, LLC recalls 5% Dextrose Injection, USP IV solution in freeflex bags due to lack of assurance of sterility. The recall affects batches 6402399, 6402400, and 6402401 with Exp 02/28/2027. Distributors nationwide, including Alaska and Puerto Rico, are notified. Stop using and contact the company for guidance and potential replacement.
Lack of Assurance of Sterility
Consumers and healthcare providers should stop using this product immediately. Contact Fresenius Kabi USA, LLC or your healthcare provider for guidance. Notification method: Letter
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This IV solution provides necessary fluids and glucose for patients unable to ingest food or fluids by mouth. It is used in hospitals and clinics.
Lack of sterility can introduce microbes into the bloodstream, causing sepsis or other infections in patients.
This recall is not part of a broader industry pattern according to available data.
Hospitals may need to substitute with other sterile IV fluids and manage inventory to avoid treatment delays.
NDC numbers are on the label. Batch numbers and expiration are printed on the bag and carton.
Refund or replacement guidance will be issued by Fresenius Kabi in the recall notification; timelines are not specified.
Keep recall letter, batch records, and correspondence; store as evidence for audits or claims
Product: 5% Dextrose Injection, USP, 5 g per 100 mL (50 mg per mL), 100 mL freeflex bag. Company: Fresenius Kabi USA, LLC. NDC: 65219-464-05 (Unit of Use), 65219-464-50 (Unit of Sale). Batches: 6402399, 6402400, 6402401. Expiration: 02/28/2027. Sold in the US including Alaska and Puerto Rico. Recall date: 2026-03-11. Status: ACTIVE.
No injuries or incidents have been reported in the provided data.
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Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Fresenius Kabi USA, LLC recalled 5% Dextrose Injection, USP, 50 mL in a 100 mL freeflex bag, distributed nationwide including Alaska and Puerto Rico. The recall cites lack of assurance of sterility. Consumers and healthcare providers should stop using this product immediately and contact Fresenius Kabi for guidance.
Fresenius Kabi USA, LLC recalls 5% Dextrose Injection, USP 12.5 g per 250 mL in FreeFlex bags due to lack of sterility assurance. The recall covers units distributed nationwide including Alaska and Puerto Rico. Healthcare providers and patients should stop use and consult a healthcare professional.