Natural Wellness Recalls Adulterated Supplements

DEERFIELD BEACH, Fla.Natural Wellness is conducting a nationwide voluntary recall of MasXtreme, after FDA testing found the product, marketed as a dietary supplement, contained undeclared drugs. The mens sexual enhancement product (Lot #907043) was found to contain undeclared amounts of aminotadalafil, an analog of tadalafil, an FDA approved drug used to treat erectile dysfunction. The presence of the drug compound makes the product an unapproved new drug; aminotadalafil is also not listed on the product label. The drug can adversely interact with other pharmaceuticals, causing dangerous drops in blood pressure.

While no adverse events have been reported to the company, customers should discontinue use of the product and return to the company or place of purchase. Adverse reactions or quality problems associated with use of the product can be reported via FDAs MedWatch Adverse Event Reporting System.

This is Natural Wellness second 2010 recall of MasXtreme. On March 30, the company announced a national recall of another lot of the product, after FDA lab testing found it contained aildenafil, which is similar in structure to a drug used to treat erectile dysfunction, and phentolamine, an alpha-adrenergic blocker. Both ingredients can cause serious adverse cardiac events in susceptible populations.