# FDA recall D-0531-2026

> **Huons Co., Ltd.** · Class II · drug recall initiated 2026-04-02.

## 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

- **Recall number:** D-0531-2026
- **Recalling firm:** Huons Co., Ltd.
- **Classification:** Class II
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0531-2026. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/D-0531-2026. Source: US FDA. Licensed CC0.

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