0.9% Sodium Chloride Injection, USP, (4
Recalled by Fresenius Kabi USA, LLC
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Fresenius Kabi USA, LLC has recalled 0.9% Sodium Chloride Injection, USP, (4, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on April 15, 2026 and was initiated on March 11, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers 0.9% Sodium Chloride Injection, USP, (4. The company behind the recall is Fresenius Kabi USA, LLC, based in Lake Zurich, IL. The FDA describes the product as: “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 ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.”
Why was 0.9% Sodium Chloride Injection, USP, (4 recalled?
According to the FDA, the stated reason for the recall is: “Lack of Assurance of Sterility.” In plain terms, this recall relates to a sterility or contamination concern.
Sterile medicines, such as injectables and eye drops, must be completely free of microorganisms and stray particles. This recall means that sterility could not be assured or that contamination was found or suspected. Using a non-sterile product of this kind can cause infections, which is why these recalls are treated seriously.
What should you do?
If you think you may have bought 0.9% Sodium Chloride Injection, USP, (4, compare it against the product description and identifying codes (Batch# 24LU10013, 24LU10014, Exp Date: 09/30/2027; Batch# 24NU10001, 24NU10002, Exp Date: 10/31/2027.) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Fresenius Kabi USA, LLC or your local health authority.
About this recall
This recall was distributed in IL. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- April 15, 2026
- Recall started
- March 11, 2026
- Distributed in
- IL
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was 0.9% Sodium Chloride Injection, USP, (4 recalled?+
According to the FDA: Lack of Assurance of Sterility
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have 0.9% Sodium Chloride Injection, USP, (4?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0428-2026. Information last synced from the FDA on July 5, 2026.