# FDA recall D-0685-2021

> **Nuri Trading LLC** · Class I · drug recall initiated 2021-03-29.

## 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.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0685-2021
- **Recalling firm:** Nuri Trading LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2021-03-29
- **Report date:** 2021-07-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fort Lee, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0685-2021

## Citation

> AI Analytics. FDA recall D-0685-2021. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/D-0685-2021. Source: US FDA. Licensed CC0.

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