The Recall Desk
SevereFDA (Drugs)·D-0456-2024·Announced 2024-05-01

The GOAT Sublingual Strip Recalled for Undeclared Prescription Drug Ingredients

The GOAT Sublingual Strip male enhancement product, distributed nationwide, was recalled for containing undeclared sildenafil and tadalafil. The product was marketed without FDA approval.

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 product is classified as FDA Class I, which establishes a minimum severity score of 4 per the rubric. The product contains undeclared prescription medications and was marketed without FDA approval, creating significant potential for harm. No illnesses have been reported.

Plain-English summary

The GOAT Sublingual Strip, a male enhancement product distributed by Hombres LLC and manufactured by Pyramids Wholesale Inc., has been recalled. All lots of the product (UPC 6 61631 26363 1) are affected.

The FDA found that the product contains undeclared sildenafil and tadalafil—prescription medications not listed on the label and marketed without FDA approval (no approved NDA or ANDA).

The product was distributed nationwide in the USA. Consumers should stop using it immediately. Anyone who has already used this product should consult a healthcare provider.

The recalled product

Product
The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres LLC, 130 Maccormick Ave, Suite 105, Costa Mesa, A, UPC 6 61631 26363 1.
Manufacturer
Pyramids Wholesale Inc.
Hazard
  • undeclared-sildenafil
  • undeclared-tadalafil
  • unapproved-drug

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.