Reported Apr 15, 2026 · Ongoing

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

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Fresenius Kabi USA, LLC · 3 Corporate Dr · Lake Zurich, IL · 60047-8930

Is this the product you have?

  • 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 NDC65219-472-05
  • Unit of Sale NDC Number65219-472-20
Lot codes and dates
    • Batch# 24LU10013
    • 24LU10014
  • Exp Date
    • 09/30/2027
    • Batch# 24NU10001
    • 24NU10002
  • Exp Date10/31/2027

This recall covers 14 products

The agency filed one notice per product. You are reading one of them; the other 13 are below.

1 more are in the archive.

Where it was sold

Why it was recalled

Lack of Assurance of Sterility

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 4:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.