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.
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
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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