0 — Class II drug recall D-0531-2026
Ongoing recall by Huons Co., Ltd., reported 2026-04-22, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0531-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Huons Co., Ltd., Jecheon, N/A, Korea (the Republic of) |
| Recall initiated | 2026-04-02 |
| Classified | 2026-05-15 |
| Reported by FDA | 2026-04-22 |
| Distributed | Nationwide (US) |
| Quantity | 7,120,750 ampules |
| Reason classes | sterility |
| NDC | 65282-1505, 65282-1505-01, 65282-1510, 65282-1510-01 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0531-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.