PlainRecalls
FDA Drug Critical Class I Ongoing

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)

Reported: October 13, 2021 Initiated: July 16, 2021 #D-0001-2022

Product Description

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

Details

Recalling Firm
Alpha-Tek LLC
Units Affected
Unknown
Distribution
Nationwide in the US
Location
Tucson, AZ

Frequently Asked Questions

What product was recalled?
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). Recalled by Alpha-Tek LLC. Units affected: Unknown.
Why was this product recalled?
Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
Which agency issued this recall?
This recall was issued by the FDA Drug on October 13, 2021. Severity: Critical. Recall number: D-0001-2022.