FDAHealthMarch 11, 2026
Fresenius Kabi USA, LLC — 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 S
⚠️ 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 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.
- Brand
- DEXTROSE
- Lot code
- Batch# 6402399, 6402400, 6402401, Exp Date: 02/28/2027.
Additional details
Batch# 6402399, 6402400, 6402401, Exp Date: 02/28/2027.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated
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