FDA Drug · D-0531-2026

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.

Class II · Ongoing

Lack of Assurance of Sterility

Affected lots / codes — check yours against thisAll lots within expiry

Recalling firm: Huons Co., Ltd., Jecheon, N/A
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 7,120,750 ampules
Distribution: USA Nationwide.
Recall initiated: April 2, 2026
Classified: May 15, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0531-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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