Shogun-X Capsules Recalled for Undeclared Prescription Drug Ingredients
Shogun-X capsules have been recalled because they contain undeclared tadalafil, sildenafil, and/or vardenafil—prescription drugs not listed on the label. These are unapproved drugs whose safety and efficacy have not been established.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I drug recall. Per the severity rubric, FDA Class I recalls receive a Critical (5) rating regardless of other factors.
Plain-English summary
Ummzy, LLC is recalling Shogun-X capsules in 10-count boxes (UPC 118122030185, manufactured by Power Life Distributors) distributed nationwide in the USA.
The recall was issued because the product contains undeclared tadalafil and/or sildenafil and vardenafil. These are prescription medications not listed as ingredients on the product label. Because they are undeclared, the product is considered an unapproved drug for which the safety and efficacy have not been established.
Consumers who have purchased this product should stop using it. Anyone with health concerns about exposure to these undeclared drugs should contact a healthcare provider.
The recalled product
- Product
- Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA, UPC 118122030185
- Manufacturer
- Ummzy, LLC
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.
Part of a larger recall action
This product is one of 3 recalled by Ummzy, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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