Recall D-0435-2026

US Class II Ongoing · initiated 2026-03-11

Recalling firm

Fresenius Kabi USA, LLC, IL

Product

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.

Reason for recall

Lack of Assurance of Sterility

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