Shogun-X 7000 Capsules Recalled for Undeclared Prescription Drug Ingredients
Nuri Trading LLC is recalling Shogun-X 7000 capsules nationwide because they contain undeclared tadalafil and sildenafil, FDA-approved prescription drugs not listed on the label, making the product an unapproved drug.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This recall meets the Critical severity threshold because it is an FDA Class I recall. Class I recalls are automatically Critical per the severity rubric.
Plain-English summary
Nuri Trading LLC is recalling Shogun-X 7000 capsules, sold in 1-count blister cards and 10-count boxes, distributed nationwide in the United States. All lots within expiry are affected.
The product was found to be tainted with undeclared tadalafil and sildenafil. Both are FDA-approved prescription drugs. Because these active ingredients are not declared on the label and the product is marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), it is considered an unapproved drug for which safety and efficacy have not been established.
Consumers who have purchased this product should stop use and consult a healthcare provider if they have questions about their health or potential exposure to these undeclared ingredients.
The recalled product
- Product
- Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
- Manufacturer
- Nuri Trading LLC
- Category
- Drug — Unapproved Drug
- Hazard
- undeclared-tadalafil
- undeclared-sildenafil
- unapproved-drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all lots within expiry
Distribution
Distributed nationwide across the United States.
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