FDA recall D-0531-2026

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.

Reason for recall

Lack of Assurance of Sterility

Distribution

USA Nationwide.

Key facts

Status

Ongoing

Initiation date

2026-04-02

Report date

2026-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Jecheon, N/A, Korea (the Republic of)

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0531-2026