FDA recall D-0001-2022

Product

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)

Reason for recall

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

Distribution

Nationwide in the US

Key facts

Status

Ongoing

Initiation date

2021-07-16

Report date

2021-10-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tucson, AZ, United States

Primary source

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