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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

Fresenius Kabi USA, LLC
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0427-2026
Classification
Class II
Recalled
March 11, 2026
Read the official notice

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