ISSUE: Evol Nutrition Associates, Inc./Red Dawn (“Evol Nutrition”) notified the public of a nationwide recall of all lots of two dietary supplement products distributed by the company under the names Mojo Nights and Mojo Nights for Her to the consumer level. Testing by the FDA revealed the presence of undeclared tadalafil and sildenafil in Mojo Nights (Evol Nutrition is also recalling Mojo Nights for Her). Tadalafil and sildenafil are active ingredients of FDA-approved drugs for Erectile Dysfunction (ED), making Mojo Nights an unapproved new drug.
These undeclared active ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
BACKGROUND: These two products were distributed nationwide via retail stores and internet sales between July 2011 and July 2012.
RECOMMENDATION: Consumers who have the recalled product in their possession should stop using the products immediately. Customers with stock of the recalled product should destroy it or return for a refund. Evol Nutrition is notifying its customers by certified mail.
[08/23/2012 - Press Release - Evol Nutrition Associates, Inc./Red Dawn]