FDA Recall D-0001-2022

Alpha-Tek LLC · Tucson, AZ

Class I — life-threatening Ongoing 1763 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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)

Lot / code: All lots within expiry

Quantity: Unknown

Reason for recall

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

Recall record

Recall number: D-0001-2022
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Distribution: Nationwide in the US
Recall initiated: 2021-07-16
Classified by FDA Center: 2021-10-04
FDA published: 2021-10-13
Recalling firm: Alpha-Tek LLC
Firm location: Tucson, AZ

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls