These products were sold as dietary supplements throughout the United States. Atlas Operations, Inc. is conducting a recall after being informed by the Food and Drug Administration (FDA) that lab analyses found that the products to contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used in the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs. The active drug ingredient is not listed on the product label.
The undeclared ingredient may pose a threat to the consumer because the interaction of the analogue with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take other prescription drugs. Erectile Dysfunction is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
The recalled products are in capsule form and may be packaged in blisters, pouches or bottles. All expiration dates of the products are included in this recall. For a complete list of the products affected see the link below.