Class IIOngoing

0.9% Sodium Chloride Injection recall

FDA recall D-0531-2026 · initiated Apr 2, 2026

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Lack of Assurance of Sterility

Details

Product: 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.
Recalling company: Huons
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: USA Nationwide.
Initiated: Apr 2, 2026
FDA report date: Apr 22, 2026

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0531-2026 ↗

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