Fresenius Kabi Sodium Chloride Injection Recall
0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC (
Updated March 11, 2026
Fresenius Kabi is recalling certain 0.9% Sodium Chloride Injection vials because the manufacturer cannot guarantee they are sterile. Using a non-sterile injectable drug 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 (9 mg per mL) in 250 mL Freeflex bags. Look for: Unit of Use NDC 65219-470-05 or Unit of Sale NDC 65219-470-30. Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, IL.
Am I affected
You're affected if you have a 250 mL Freeflex bag of 0.9% Sodium Chloride Injection with NDC 65219-470-05 or 65219-470-30 and have not yet used it. This is a prescription drug, so check your hospital pharmacy or medical supplier.
What to do right now
Stop using this product immediately and contact your hospital pharmacy, clinic, or medical supplier. Do not use any remaining vials of this medication. Your healthcare provider will provide an alternative sterile saline solution.
The hazard
Lack of Assurance of Sterility
Brands affected
- Source
- FDA
- Category
- Drugs & Medications
- Recall ID
- fda-D-0427-2026
- Classification
- Class II
- Recalled
- March 11, 2026
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