0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only

Huons Co., Ltd. has recalled 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on April 22, 2026 and was initiated on April 2, 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, 10 mL Ampules, Rx only, with approximately 7,120,750 ampules affected. The company behind the recall is Huons Co., Ltd., based in Jecheon, N/A. The FDA describes the product as: “0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.”

Why was 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only 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, 10 mL Ampules, Rx only, compare it against the product description and identifying codes (All lots within expiry) 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 Huons Co., Ltd. or your local health authority.

About this recall

This recall was distributed in N/A. 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.