FDA Drug recall D-0685-2021
Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
- FDA Drug
- Class I
- ongoing
- Published 2021-07-28
On 2021-07-28 the FDA classified a Class I recall of Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC by Nuri Trading, citing 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 safe….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0685-2021 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-03-29 |
| Published | 2021-07-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Nuri Trading |
| Distribution | US |
Product
Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
Reason
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.
Identifiers
| code_info | all lots within expiry |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0685-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.