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High risk Drugs & MedicationsClass II

Fresenius Kabi Sodium Chloride Injection Recall

0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LL

Updated March 11, 2026

Fresenius Kabi is recalling a 0.9% Sodium Chloride Injection due to lack of assurance of sterility. This injectable medication may not be sterile, which could cause serious infection if used.

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) in 100 mL Freeflex bags. Product manufactured by Fresenius Kabi USA, LLC, Lake Zurich, IL. Unit of Use NDC: 65219-468-05. Unit of Sale NDC: 65219-468-50. Prescription only.

Am I affected

You're affected if you have this medication in your possession with NDC number 65219-468-05 or 65219-468-50 on the package label, or if you recently received this IV saline injection from a healthcare provider.

What to do right now

Do not use this product. If you have received this injection as a patient, contact your healthcare provider immediately. Healthcare facilities should contact Fresenius Kabi USA or their supplier for recall instructions and replacement product.

The hazard

Lack of Assurance of Sterility

Brands affected

Fresenius Kabi USA, LLC
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0426-2026
Classification
Class II
Recalled
March 11, 2026
Read the official notice

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