The Recall Desk
CriticalFDA (Drugs)·D-0654-2020·Announced 2020-01-22

FDA Recalls Unapproved Bull Platinum 30000 Capsules Containing Tadalafil

Motto International Corp is recalling Bull Platinum 30000 Capsules because FDA analysis found the product contains tadalafil, a prescription drug, and it was marketed without an approved NDA or ANDA.

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 per the rubric mandates a score of 5 (Critical) regardless of other factors.

Plain-English summary

Motto International Corp is recalling Bull Platinum 30000 Capsules, 1000 mg, packaged in 2, 4, and 10 count blister cards. The product is described as having an orange, white, and yellow background with silver text. The recall involves 8 boxes of the product.

The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis determined that the product contains tadalafil, an active ingredient found in prescription medications. The recall covers all lots remaining within their expiration dates.

The product was distributed in Texas. Consumers who possess this product should stop using it and contact the recalling firm for further instructions or a refund.

The recalled product

Product
Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background with silver text, packaged in 2, 4 and 10 count blister cards, Motto International, Dallas, TX
Affected units
8

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 →