Male Performance Enhancer Recalled for Undeclared Sildenafil and Tadalafil
ALPHASTRIP Male Performance Enhancer strips are being recalled nationwide because they contain undeclared sildenafil and tadalafil. The product was marketed without FDA approval.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recalls are never scored below Severe (4) per the rubric. No illnesses or injuries have been reported. The Class I designation reflects serious potential for adverse health consequences due to the presence of unapproved prescription drugs.
Plain-English summary
ALPHASTRIP Male Performance Enhancer is a sublingual strip product manufactured by Pyramids Wholesale Inc. and distributed by GALT INT'L. The FDA has recalled all lots of the product due to the discovery of undeclared sildenafil and tadalafil.
The product was marketed without an FDA-approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The recall designation is Class I. A total of 4,351 pieces were distributed nationwide.
Consumers who have obtained or used ALPHASTRIP should stop using the product immediately and contact a healthcare provider, especially if they experience any adverse symptoms or have underlying health conditions or take other medications.
The recalled product
- Product
- ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L
- Manufacturer
- Pyramids Wholesale Inc.
- Affected units
- 4,351
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.
Part of a larger recall action
This product is one of 11 recalled by Pyramids Wholesale Inc. 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.
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