The Recall Desk
CriticalFDA (Drugs)·D-0663-2021·Announced 2021-07-28

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.

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 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
Category
Drug — Unapproved Drug / Undeclared Active Ingredients
Hazard
  • undeclared-medication
  • unapproved-drug
  • erectile-dysfunction-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.

Related recalls

Same category