The Recall Desk
CriticalFDA (Drugs)·D-0655-2020·Announced 2020-01-22

FDA Recalls Unapproved Stallion Platinum 30000 Capsules Containing Tadalafil

Motto International Corp is recalling Stallion Platinum 30000 Capsules because FDA analysis found the unapproved product contains tadalafil.

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: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Motto International Corp is recalling Stallion Platinum 30000 Capsules, packaged in 2, 4, and 10 count blister cards. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

The recall was initiated because FDA analysis determined that the product contains tadalafil. The recall covers all lots remaining within their expiration dates. The product was distributed in Texas.

Consumers who have purchased this product should stop using it and contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
Stallion Platinum 30000 Capsules in blue,orange,white background with red,white text in hologram paper packaging, packaged in 2, 4, 10 count blister cards, Motto International, Dallas, TX
Affected units
7

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 remaining within expiry.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 4 recalled by Motto International Corp 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.

See all 4 products in this recall →