FDA Recalls Blue Male Enhancement Pill for Unapproved Ingredient
The Menz Club is recalling Blue Male Enhancement Pill because it contains sulfoaildenafil, an unapproved analogue of sildenafil.
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
The Menz Club, LLC is recalling 50,000 capsules of Blue Male Enhancement Pill, a bulk product manufactured in Ridgeland, Mississippi. The product was distributed in Utah.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Testing revealed the presence of sulfoaildenafil, an analogue of sildenafil, which is the active ingredient in FDA-approved products used for erectile dysfunction. Consequently, the product is classified as an unapproved new drug.
Consumers who purchased this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS
- Manufacturer
- The Menz Club, LLC
- Category
- Drug — Unapproved New Drug
- Affected units
- 50,000
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)
- None
Distribution
Distributed in 1 state:
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