Male Sexual Enhancement Product Recalled for Undeclared Pharmaceutical Ingredients
Pyramids Wholesale Inc. is recalling all lots of GoHARD 25000 because it contains undeclared sildenafil and tadalafil. The product was marketed without FDA approval for these prescription-strength drugs.
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: This is an FDA Class I recall. The presence of undeclared prescription-strength pharmaceutical ingredients (sildenafil and tadalafil) in a product marketed as a natural dietary supplement poses significant health risks from drug interactions and contraindications, particularly because consumers are unaware they are consuming these potent medications.
Plain-English summary
Pyramids Wholesale Inc. is recalling all lots of GoHARD 25000, a male sexual enhancement product marketed as 100% natural honey. The product is distributed nationwide in the United States.
The FDA identified that GoHARD 25000 contains undeclared sildenafil and tadalafil, which are prescription-strength pharmaceutical ingredients. The product was marketed and distributed without an FDA-approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Consumers using this product unknowingly exposed themselves to prescription drugs marketed as a natural dietary supplement.
Consumers who have purchased or used GoHARD 25000 should stop using the product immediately and contact their healthcare provider. Because these undeclared prescription drugs may interact with other medications or be contraindicated for certain health conditions, medical consultation is important for anyone exposed to this product. The product should not be used or distributed.
The recalled product
- Product
- GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A.
- Manufacturer
- Pyramids Wholesale Inc.
- Affected units
- 12
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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