FDA Drugs recall ·
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose… recall
- Recall number
- D-0531-2026
- Date
- (initiated April 2, 2026)
- Company / brand
- Huons Co., Ltd.
100 Bio-Valley-Ro, Jecheon, N/A, Korea (the Republic of) - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7,120,750 ampules
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Lack of Assurance of Sterility
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All lots within expiry
Distribution
USA Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0531-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.