FDAFDA · Food and drugs·Recall number D-0437-2026
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.
Published April 15, 2026 · Recall initiated: March 11, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DEXTROSE
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- US Nationwide , Alaska, and Puerto Rico.
- Lot
- Batch# 6402165, Exp Date: 05/30/2028.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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