Natural Remedy Store has voluntarily recalled all lots of Active Male 500mg Capsules after they were found to be tainted with undeclared tadalafil.
The U.S. Food and Drug Administration (FDA) analyzed the product and found that it was tainted with tadalafil, a prescription drug.
Tadalafil, sold under the brand name Cialis, is recommended for the treatment of erectile dysfunction (ED), a condition in which men fail to get or keep an erection hard and long enough for sexual intercourse.
The FDA said the presence of tadalafil has rendered the product an unapproved drug, with no guarantee of safety and efficacy, prompting the agency to recall it.
Taking products containing undeclared tadalafil could be dangerous for people who take prescription drugs containing nitrates (nitroglycerin) or alpha-blockers.
The combination of tadalafil and nitrates or alpha-blockers could lower your blood pressure to a potentially dangerous level. Patients with high blood pressure, heart disease, high cholesterol, or diabetes often take nitrates and/or alpha-blockers.
So far, Natural Remedy Store has not received any adverse events related to the product that is sold as a dietary supplement for men to boost their sexual health.
Active Male capsules were distributed at the Natural Remedy Store in San Antonio TX. They were also sold online through the naturalremedystore.com website.
The store is notifying consumers through a press release, recall notice, and by displaying a notice on its retail counter in San Antonio TX. The company is also arranging a refund or replacement of the product.
The FDA warned people to discontinue using the product and return it to the store. The agency also advised consumers to report any side effects after using the product to their doctors.