Recall: D-0436-2026
Class II - Potentially Harmful
Class IIClassification
2026-03-11Initiated
OngoingStatus
Fresenius Kabi USA, LLCFirm
Product
5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-50.
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.