US Drug Recall Register
Class I · High risk Terminated Initiated Jan 8, 2019 (8 years ago)

5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together…

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil

What was recalled

5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644

Recalling firm
Happy Together, Inc.
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0388-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.