Biotab Nutraceuticals and the FDA announced a voluntary recall of Extenze nutritional supplements after two lots of counterfeit products were found. The FDA notified Biotab after discovering that lots #0709241 and #0509075 were counterfeit products purporting to be Extenze. These lots contained undeclared ingredients, specifically, lot #0709241 contains tadalafil and sildenafil and lot #0509075 contains tadalafil and sibutramine. The counterfeit products are sold in the form of carded four-packs (Lot# 0709241) and in the form of a box of 30 tablets divided into two 15-tablet blister packs (Lot# 0509075).  

The counterfeit Extenze product is not manufactured, distributed or packaged by Biotab, but is falsely marked with the same lot numbers used by Biotab for its genuine product. Because it is very difficult to distinguish the counterfeit from the genuine product, Biotab decided to conduct this voluntary recall of the two affected lots. It is possible that there may be other counterfeit products on the market that have yet to be identified.

Tadalafil and sildenafil are drugs used to treat erectile dysfunction. These drugs may interact with nitrates found in some prescription drugs (eg, nitroglycerin) and may lower blood pressure to dangerous levels. Patients with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Sibutramine is a controlled substance indicated for the management of obesity, which was withdrawn from the market in October 2010. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

Patients with the recalled products in their possession should stop using them immediately.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm244369.htm.