Huons Co., Ltd. recalls 0.9% Sodium Chloride Injection
- Recalling company
- Huons Co., Ltd.
- 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
- Lack of Assurance of Sterility
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 2, 2026
- Reported
- Apr 22, 2026
- Distribution
- USA Nationwide.
- Status
- Ongoing
- Quantity
- 7,120,750 ampules
- Lot / codes
- All lots within expiry
- Company location
- Jecheon, N/A
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0531-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0531-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.