Recall: D-0435-2026

Class II - Potentially Harmful

Class IIClassification
2026-03-11Initiated
OngoingStatus
Fresenius Kabi USA, LLCFirm

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

Lack of Assurance of Sterility

Distribution

US Nationwide , Alaska, and Puerto Rico.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.