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
- Source
- FDA
- Category
- Drugs & Medications
- Recall ID
- fda-D-0432-2026
- Classification
- Class II
- Recalled
- March 11, 2026
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