Huons Co. product recalled over sterility concerns
- Recall date
- April 2, 2026
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Huons Co., Ltd. recalls 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra…
- Recall number
- D-0531-2026
- FDA classification
- Class II
- Brand / firm
- Huons Co., Ltd.
- Sold / distributed
- USA Nationwide.
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was 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.
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