Natural Remedy Store has issued a voluntary recall on all lots of their supplement “Active Male,” 500mg capsules, after an FDA analysis found that the product contained undeclared tadalafil. Tadalafil itself is an FDA-approved drug for the treatment of erectile dysfunction, but the presence of the drug in this product, the combination of ingredients, and the lack of appropriate labeling makes it unapproved and subject to recall.

Consuming a product containing tadalafil may pose a risk to those who take prescription medications containing nitrates, such as nitroglycerin. These two drugs combined can cause a life-threatening drop in blood pressure.

Those with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and are most at risk in this situation. To date, however, Natural Remedy Store has not received complaints about any adverse side effects.

The tainted Active Male product is marketed as a dietary supplement for male enhancement to boost sexual performance and is packaged in small, foldable cardboard with an image of a Trojan helmet and the name Active Male with BN: Nd6332.

The product was distributed at the Natural Remedy Store in San Antonio, Texas, and was also sold through the Natural Remedy Store website.

Arrangements for product returns and replacements are being made. Those who have the recalled product should stop using it and return it to the place of purchase or call Natural Remedy Store immediately to set up a return.

To ask questions about this recall or arrange a return, please call Natural Remedy Store at (210) 798-5433. Hours of availability are Monday through Saturday, 10 a.m. to 6 p.m. central time. The store may also be contacted any time by emailing natremedies@att.net.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

For mail or fax: download a form or request one by calling 1-800-332-1088, then return it to the address on the pre-addressed form. A fax may be sent to 1-800-FDA-0178.

This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.