Safety Report: Alpha Male Plus Male Enhancer fruit chew - recalled due to undeclared Tadalafil, USA

United States

Company name: Alpha Male Plus
Brand name: Alpha Male Plus
Product recalled: Alpha Male Plus Male Enhancer fruit chew
Reason of the recall: Undeclared Tadalafil
FDA Recall date: July 19, 2021
Recall details: Tucson, AZ, Alpha Male Plus is voluntarily recalling all lots within expiry of Alpha Male Plus Male Enhancer fruit chews to the consumer level. FDA analysis has found the product to be tainted with tadalafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in a FDA approved product for the treatment of male erectile dysfunction. The presence of tadalafil in Alpha Male Plus Male Enhancer renders the product an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Risk Statement: Consumers with underlying medical conditions who take Alpha Male Plus Male Enhancer with undeclared tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Alpha Male Plus has not received any reports of adverse events related to this recall.

The tainted Alpha Male Plus Male Enhancer product was manufactured by Dr Manuel Mascarenas M.D. in Tucson, Arizona located at 5190 E Farness Dr Ste 104, 85712. Dr Mascarenas is the originator and manufacturer of these products for the global market. Alpha Male Plus was selected to act as the US distributor and distribute these products for the US market.

The tadalafil ingredient was never disclosed or made known to its US distributor and was only discovered through FDA laboratory analysis. Dr Manuel Mascarenas is solely responsible for the creation, formulation and proliferation of this product. Through the use of concealment, dishonest means and an unknowing 3rd party Dr Mascarenas was able to begin distributing this mislabeled and potentially harmful product to the US market.

Alpha Male Plus was marketed as a dietary supplement for male sexual enhancement and is packaged in 1strip per foil pouch within a cardboard box, UPC [8 60003 03770 6] [8 60003 74512 0].

The affected Alpha Male Plus Male Enhancer includes all lots. The product was distributed nationwide in the USA via internet directly to consumers via their website.

Company is notifying its distributors and customers by e-mail and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using or return to place of purchase/discard/contact their doctor, etc.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/alpha-male-plus-issues-voluntary-nationwide-recall-alpha-male-plus-male-enhancer-due-presence

Source: FDA