Stiff Boy LLC Recalls The Beast Due to Undeclared Sildenafil
Stiff Boy LLC is recalling The Beast because FDA analysis found undeclared sildenafil. The product was marketed without an approved NDA or ANDA.
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
Stiff Boy LLC is voluntarily recalling 1,000 boxes of The Beast, a product described as containing 4,600 mg in 4 capsules per packet. The recall covers all lots and was distributed nationwide.
The recall was initiated because FDA analysis discovered that the product contains undeclared sildenafil. Additionally, the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Consumers who have purchased The Beast should stop using the product and contact Stiff Boy LLC for further instructions or a refund.
The recalled product
- Product
- The Beast, The Beast can be taken under the situation of Heart disease and even after drinking, 4600 mg X 4 Capsules per packet.
- Manufacturer
- Stiff Boy LLC
- Category
- Drug — Unapproved Supplement
- Affected units
- 1,000
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
Distribution
Distributed nationwide across the United States.
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