The California-based company Esupplementsales is voluntarily recalling lot number 2107 of Hard Dawn Rise and Shine capsules. The recall happened after Amazon told the company that a laboratory analysis has determined its product to be tainted with tadalafil, an ingredient known as a phosphodiesterase inhibitor found in FDA-approved products for the treatment of male erectile dysfunction.
According to the risk statement associated with the FDA's published recall notice,"Consumers with underlying medical conditions who take Hard Dawn Rise and Shine with undeclared tadalafil may experience serious health risks." For example, PDE-5 inhibitors could interact with nitrates found in some prescription drugs . This interaction could lower blood pressure to a level that could be dangerous or even life threatening. People who have common conditions such as diabetes, high blood pressure, or heart disease often take nitrates. Fortunately, at this time Esupplementsales has not received any reports of health problems related to these products.