FDAFDA · Food and drugs·Recall number D-0428-2026

0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.

Name: 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.
Brand: SODIUM CHLORIDE

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# 24LU10013, 24LU10014, Exp Date: 09/30/2027; Batch# 24NU10001, 24NU10002, Exp Date: 10/31/2027.
Risk classification: Class II
Area (FDA): drug
Country: United States

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