Fresenius Kabi USA, LLC: 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 m

Fresenius Kabi USA, LLC: 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Uni

DrugsSource: FDA (drug) · Date: 2026-04-15

The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand: Fresenius Kabi USA, LLC
Product: 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30.
Reason / hazard: Lack of Assurance of Sterility
Classification: Class II
Status: Ongoing
Distribution / sold at: US Nationwide , Alaska, and Puerto Rico.
Recall initiated: 2026-03-11
Code info: Batch# 6402165, Exp Date: 05/30/2028.
Voluntary mandated: Voluntary: Firm initiated
City: Lake Zurich
State: IL
Country: United States
Event id: 98581