Shogun-X 7000 capsule — Class I drug recall D-0685-2021
Ongoing recall by Nuri Trading LLC, reported 2021-07-28, distributed nationwide. Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, t
| Recall number | D-0685-2021 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nuri Trading LLC, Fort Lee, NJ, United States |
| Recall initiated | 2021-03-29 |
| Classified | 2021-07-19 |
| Reported by FDA | 2021-07-28 |
| Distributed | Nationwide (US) |
| Reason classes | undeclared allergen, unapproved product |
Product
Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
Reason for recall
Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
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-0685-2021. 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.