The Recall Desk
SevereFDA (Drugs)·D-0453-2024·Announced 2024-05-01

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.
Hazard
  • undeclared-drugs
  • sildenafil
  • tadalafil

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.