All lots of the Euphoric male enhancement supplement have been voluntarily recalled by Epic Products, LLC after the US Food and Drug Administration (FDA) discovered the presence of undeclared prescription erectile dysfunction products.
The product, packaged in one count blister cards, three count bottles and 123 count bottles at the consumer level, was sold to consumers across the United States via retail stores. It is marketed as a dietary supplement to aid male sexual enhancement, yet the FDA found it contained two PDE-5 inhibitors, sildenafil and tadalafil. The presence of these medications categorizes the product as an unapproved drug and means it is subject to recall.
Sildenafil is the active ingredient in the erectile dysfunction drug Viagra and tadalafil is the active ingredient in Cialis. As Euphoric is an unapproved drug, its safety and efficacy have not been established by the FDA.
Explaining the risks associated with using PDE-5 inhibitors the FDA warned that consumers taking the product for erectile dysfunction could have an underlying heart condition or cardiovascular disease. Patients with diabetes, high cholesterol, hypertension or heart disease are often prescribed nitrates, such as Dilatrate-SR (isosorbide dinitrate), which can lead to fatal cardiovascular collapse when used alongside PDE-5 inhibitors.
Last month, the FDA warned consumers against use or purchase of drugs advertised as a “healthy man alternative to the little blue pill”, “healthy man”, or the “power pill”. The products were advertised on radio and internet platforms across the country, but the FDA confirmed the unapproved products contained 100mg of sildenafil.
At the time, it reiterated its warning to consumers against purchasing medications from unapproved or unlicensed sources, as they may be fake, contaminated, subject to improper storage or transportation, or otherwise unsafe or ineffective.
To date, no adverse events related to the recall of the Euphoric capsules have been reported the the FDA. Consumers with questions concerning the recall were advised to call 1-800-589-1470. Any adverse reactions or problems associated with taking the recalled product can be reported to the FDA’s MedWatch Adverse Event Reporting program.