FDAFDA · Food and drugs·Recall number D-0424-2026
0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).
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
- SODIUM CHLORIDE
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- US Nationwide , Alaska, and Puerto Rico.
- Lot
- Batch # 6402413, Exp Date: 02/29/2028
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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