FDA-Drug2021-10-13Class IMISBRANDING

Alpha-Tek Alpha Male+ male enhancer recalled for undisclosed prescription drug ingredient

UNAPPROVED DRUGSNationwide distribution

Stop using Alpha Male+ male enhancer strips

Alpha Male+ fruit chew strips contain tadalafil, a prescription medication, but were sold without FDA approval. The product was marketed as a dietary supplement without disclosing this active pharmaceutical ingredient. No injuries have been reported.

  • Stop using Alpha Male+ strips immediately if you have them
  • Do not take any remaining strips
  • Consult your doctor if you have taken this product and have concerns
  • Dispose of the product safely
Hazard

Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil

Sold states
Nationwide in the US
Affected count
Unknown
Manufactured in
3280 E Hemisphere Loop, Suite 190, Tucson, AZ, United States
Products
ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0001-2022

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief