RecalledThisWeek Search
High risk Drugs & MedicationsClass II

Fresenius Kabi Sodium Chloride Injection Recall

0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC (

Updated March 11, 2026

Fresenius Kabi is recalling 0.9% Sodium Chloride Injection due to lack of assurance of sterility. This injectable medication may be contaminated, which could cause serious infection if administered.

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 (4,500 mg per 500 mL / 9 mg per mL) in 500 mL Freeflex bags made by Fresenius Kabi USA, LLC. Affected NDC numbers: Unit of Use 65219-472-05, Unit of Sale 65219-472-20.

Am I affected

You are affected if you have received or have in stock this product with NDC 65219-472-05 (Unit of Use) or 65219-472-20 (Unit of Sale), or if your healthcare facility has received these intravenous bags from Fresenius Kabi.

What to do right now

If you are a healthcare provider or patient who has received this medication, contact your healthcare facility immediately. Do not use this product. Return unused bags to Fresenius Kabi or your supplier, and follow your facility's protocol for handling recalled injectable medications.

The hazard

Lack of Assurance of Sterility

Brands affected

Fresenius Kabi USA, LLC
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0428-2026
Classification
Class II
Recalled
March 11, 2026
Read the official notice

Get free recall alerts

New Drugs & Medications recalls, the moment they post.

Free forever. Unsubscribe anytime. We never sell your data.

More Drugs & Medications recalls