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.
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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5% Dextrose Injection is used to provide calories and fluid therapy in clinical settings. In 250 mL FreeFlex bags, it is designed for IV administration.
Lack of sterility assurance raises risk of infection or contamination during IV treatment, which can be life-threatening in vulnerable patients.
This recall is not part of a broader industry pattern.
Hospitals and clinics must audit IV fluid inventories and isolate affected lots to prevent use; patients may require alternative therapies and monitoring.
FDA recall page and Fresenius Kabi communications; unit labels and lot records in pharmacy
Replacement or refund processing timelines are facility dependent; typical ranges are 2-8 weeks depending on hospital systems and supplier processes
Document batch number, expiration date, lot, and efforts to contact supplier; retain correspondence and inventory reports
Brand: DEXTROSE; Brand owner: Fresenius Kabi USA, LLC; Product: 5% Dextrose Injection, USP 12.5 g/250 mL in 250 mL FreeFlex bag; Unit of Use NDC: 65219-458-05; Unit of Sale NDC: 65219-458-30; Batch: 6402165; Expiration: 05/30/2028; Distribution: US Nationwide, Alaska, Puerto Rico; Recall date: 2026-03-11; Status: ACTIVE.
No incident counts are provided in the source material.
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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 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.
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.