The Recall Desk
CriticalFDA (Drugs)·D-0388-2019·Announced 2019-01-30

5K Premium Enhancement capsules recalled for undeclared sildenafil and tadalafil

Happy Together, Inc. is recalling 5K Premium Enhancement capsules because FDA analysis found undeclared sildenafil and tadalafil.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a score of 5 per the rubric.

Plain-English summary

Happy Together, Inc. is recalling 5K Premium Enhancement capsules, 5000 mg, 1 count blister card, box of 30. The product was sold over the internet.

The FDA is recalling this product because it was marketed without an Approved NDA/ANDA. FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil.

Consumers who have this product should stop using it and contact the manufacturer for further instructions.

The recalled product

Product
5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644
Manufacturer
Happy Together, Inc.
Category
Drug — Dietary Supplement
Hazard

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 within expiry

Distribution

Distribution scope not specified by the agency.

Related recalls

Same hazard · undeclared drug

See all →