Reported Apr 15, 2026 · Ongoing

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

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?

  • 0.45% 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 NDC63323-626-03
  • Unit of Sale NDC Number63323-626-25 (30 bags in 1 case)
Lot codes and dates
  • Batch # 6402413
  • Exp Date02/29/2028

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, 3:29 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.