The U.S. Food and Drug Administration is warning consumers not to purchase or use Rhino male enhancement products, due to a recent rise in reported health issues. Since 2007, the FDA has identified more than 25 products marketed with variations of the name “Rhino” that contained hidden drug ingredient(s).

The products continue to be sold at gas stations and convenience stores, as well as on websites such as eBay and Amazon. More recently, the unapproved products have been discovered in international mail shipments to the U.S. They often are sold in single-serving package sizes. Rhino products include names such as Platinum Rhino 25000, Krazzy Rhino 25000, and Gold Rhino 25000.

The FDA has received reports of people experiencing chest pain, severe headaches, and prolonged erections after taking a Rhino product that led to surgical intervention and hospitalization due to extreme drops in blood pressure.

Since 2015, the FDA’s Office of Criminal Investigations has been investigating a South Korean national living in the Los Angeles area for smuggling raw materials, producing Rhino capsules and distributing the misbranded drug products throughout the U.S. The case led to an indictment, which is being prosecuted by the U.S. Department of Justice. The FDA continues to pursue regulatory and criminal actions against those who violate federal law. 

The FDA has posted warnings that these Rhino products contain undeclared ingredients that are the same as or structurally similar to active ingredients found in FDA-approved prescription drugs used to treat erectile dysfunction. For example, the FDA has identified various Rhino products containing sildenafil and/or tadalafil, the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively.

These undeclared ingredients are phosphodiesterase type-5 (PDE-5) inhibitors, which can be associated with significant safety issues and the risk of serious adverse events. For example, they may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

(Source: U.S. Food and Drug Administration)