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High risk Drugs & MedicationsClass II

Fresenius Kabi Sodium Chloride Injection Recall

0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA

Updated March 11, 2026

Fresenius Kabi is recalling 0.45% Sodium Chloride Injection in 250 mL bags because the company cannot guarantee the product is sterile. Non-sterile injectable solutions can cause serious infections.

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

What is recalled

0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL Freeflex bag, made by Fresenius Kabi USA, LLC. Unit of Use NDC: 63323-626-03. Unit of Sale NDC: 63323-626-25 (30 bags per case).

Am I affected

You're affected if you have this product in your facility or pharmacy: Check the package for NDC number 63323-626-03 (individual bag) or 63323-626-25 (case of 30). This is a prescription-only injectable, typically found in hospitals, clinics, and pharmacies.

What to do right now

Stop using this product immediately. If you received or used any of these bags, contact Fresenius Kabi USA, LLC or your healthcare facility's pharmacist or infection control team to report the lot and verify next steps.

The hazard

Lack of Assurance of Sterility

Brands affected

Fresenius Kabi USA, LLC
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0424-2026
Classification
Class II
Recalled
March 11, 2026
Read the official notice

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