Drug marketed as 'male enhancement' supplement under scrutiny

All men need to be more careful before taking supplements now.

The FDA urgently announced the recall of a “male enhancement” supplement after it was discovered that the product contained two erectile dysfunction drugs that were not declared on the label.

StuffbyNainax LLC is voluntarily recalling all lots of MR.7 SUPER 700000 capsules, sold as a dietary supplement, after testing showed the product contained erectile dysfunction drugs sildenafil and tadalafil.

Sildenafil, sold under the brand name Viagra and Revatio, and tadalafil, sold under the brand name Cialis, are FDA-approved prescription drugs and active ingredients used to treat male erectile dysfunction.

They belong to a class of drugs known as phosphodiesterase type 5 (PDE 5) inhibitors, and products containing sildenafil or tadalafil cannot be marketed as dietary supplements, the FDA recall noted.

MR.7 SUPER 700000 is an unapproved product and safety and efficacy have not been established for it.

The FDA does not regulate dietary supplements with the same procedures that the use for prescription drugs, however, the agency does step in to issue warnings and recalls after a problem has been reported.

While they are FDA-approved, taking sildenafil and tadalafil carries notable side effect risks, including headache, indigestion, back pain, muscle aches and dizziness.

The male enhancement product was distributed nationwide “to a limited number of online customers between August 2025 and November 2025,” according to the FDA.

Taking sildenafil or tadalafil can be dangerous for the millions of people taking medication to treat chest pain, such as nitroglycerin. Combining them can result in a critical drop in blood pressure.

This can cause dizziness, fainting, falls, heart attack or stroke due to the brain and heart not receiving enough blood flow.