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.
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: 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
- Manufacturer
- Motto International Corp
- Category
- Drug — Unapproved Supplement
- 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 →Related recalls
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