Atlas Operations is conducting a voluntary recall after being informed by the 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.
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.