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High risk Drugs & MedicationsClass II

Fresenius Kabi Sodium Chloride Injection Recall

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fre

Updated March 11, 2026

Fresenius Kabi USA is recalling 0.9% Sodium Chloride Injection 500 mL single-dose bags because the manufacturer cannot confirm the product is sterile. Sterile injectable solutions are critical for patient safety, and non-sterile injections can cause serious infection.

Is the Fresenius Kabi USA, LLC recalled? Yes. This product was recalled by FDA on March 11, 2026. Details below.

What is recalled

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL single-dose freeflex bags. Pack size: 500 mL x 20. NDC (Unit of Use): 65219-432-20. NDC (Unit of Sale): 65219-432-85. Manufactured for Fresenius Kabi USA, LLC, IL 60047.

Am I affected

You are affected if you have this product in a healthcare setting (hospital, clinic, pharmacy). Check the package for NDC number 65219-432-20 or 65219-432-85 and the Fresenius Kabi USA, LLC name.

What to do right now

Stop using this product immediately. Contact your healthcare facility's pharmacy or Fresenius Kabi USA, LLC to report the affected product and arrange for return or replacement. Do not use the recalled sodium chloride injection for any patient.

The hazard

Lack of Assurance of Sterility

Brands affected

Fresenius Kabi USA, LLC
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0432-2026
Classification
Class II
Recalled
March 11, 2026
Read the official notice

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