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FDA · Drugs ·

0.9% Sodium Chloride Injection recall

Huons Co., Ltd. recalled 0.9% Sodium Chloride Injection on April 22, 2026 because of lack of Assurance of Sterility. It was sold nationwide.

Why it was recalled

Lack of Assurance of Sterility

What's recalled

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.

Quantity: 7,120,750 ampules

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Huons Co., Ltd., Jecheon, N/A
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
USA Nationwide.
Status
Ongoing
Recall number
D-0531-2026
Source
U.S. Food and Drug Administration

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