FDAHealthMarch 11, 2026
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"), Unit of Use NDC: 65219-458-05, Unit o
⚠️ Lack of Assurance of Sterility
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 11, 2026
US Nationwide , Alaska, and Puerto Rico.
What's affected?
- 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.
- Brand
- DEXTROSE
- Lot code
- Batch# 6402165, Exp Date: 05/30/2028.
Additional details
Batch# 6402165, Exp Date: 05/30/2028.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated
Get Health recall alerts
Delivered to your inbox. Free. No account required.