FDA has identified an emerging trend where over-the-counter products, frequently represented as dietary supplements, contain hidden active ingredients that could be harmful. Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients. These deceptive products can harm you! Hidden ingredients are increasingly becoming a problem in products promoted for sexual enhancement.
Monkey Business
May 3, 2017 – The Food and Drug Administration (FDA) is advising consumers not to purchase or use Monkey Business, a product promoted for sexual enhancement.
FDA laboratory analysis confirmed that Monkey Business contains N-desmethyl tadalafil. N-desmethyl tadalafil is an analogue of tadalafil, the active ingredient in Cialis, an FDA-approved prescription drug for erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Z Daily
May 3, 2017 – The Food and Drug Administration (FDA) is advising consumers not to purchase or use Z Daily, a product promoted for sexual enhancement.
FDA laboratory analysis confirmed that Z Daily contains homosildenafil. Homosildenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Big N Hard
May 3, 2017 – The Food and Drug Administration (FDA) is advising consumers not to purchase or use Big N Hard, a product promoted for sexual enhancement.
FDA laboratory analysis confirmed that Big N Hard contains tadalafil, the active ingredient in Cialis, an FDA-approved prescription drug for erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Xrect
May 3, 2017 – The Food and Drug Administration (FDA) is advising consumers not to purchase or use Xrect, a product promoted for sexual enhancement.
FDA laboratory analysis confirmed that Xrect contains tadalafil and descarbonsildenafil. Tadalafil is the active ingredient in Cialis, an FDA-approved prescription drug for erectile dysfunction (ED). Descarbonsildenafil is structurally similar to sildenafil, the active ingredient in Viagra, also an FDA-approved prescription drug for ED. These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Tornado
May 3, 2017 – The Food and Drug Administration (FDA) is advising consumers not to purchase or use Tornado, a product promoted for sexual enhancement.
FDA laboratory analysis confirmed that Tornado contains nortadalafil. Nortadalafil is structurally similar to tadalafil, the active ingredient in Cialis, an FDA-approved prescription drug for erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Cummor
May 3, 2017 – The Food and Drug Administration (FDA) is advising consumers not to purchase or use Cummor, a product promoted for sexual enhancement.
FDA laboratory analysis confirmed that Cummor contains N-desmethyl tadalafil. N-desmethyl tadalafil is an analogue of tadalafil, the active ingredient in Cialis, an FDA- approved prescription drug for erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
You can view all previous & future notices on fda.gov.