The US Food and Drug Administration (FDA) has issued an urgent nationwide recall for a so-called 'male enhancement' dietary supplement. The product, named MR.7 SUPER 700000 capsules, was found to be contaminated with two powerful prescription drugs used to treat erectile dysfunction, which were not listed on its label.
Contaminated Product Poses Serious Health Risks
The manufacturer, StuffbyNainax LLC, is voluntarily recalling all lots of the supplement. Independent testing revealed the capsules contained sildenafil and tadalafil. These are the active ingredients in the FDA-approved prescription medications Viagra and Cialis, respectively.
These drugs belong to a class known as phosphodiesterase type‑5 (PDE‑5) inhibitors. Crucially, the FDA states that products containing sildenafil or tadalafil cannot be legally marketed as dietary supplements. MR.7 SUPER 700000 is an unapproved product, and its safety and efficacy have never been established.
Consuming these undeclared drugs carries significant risks. Side effects can include headaches, indigestion, back pain, muscle aches, and dizziness. The danger is particularly acute for individuals taking nitrate medications for chest pain, such as nitroglycerin.
A Widespread and Recurring Problem
The contaminated product was distributed nationwide to a limited number of online customers between August 2025 and November 2025. The affected capsules do not carry lot numbers or expiration dates, complicating identification.
This incident is not isolated. The FDA has issued more than 400 similar public warnings and recalls since 2012 for various male enhancement supplements, often sold under names like Rhino 69 and Man Fuel. These products frequently contain hidden, potentially harmful prescription drug ingredients.
The regulatory landscape for dietary supplements differs greatly from that for prescription drugs. The FDA does not routinely test supplements before they are marketed, nor does it validate their safety or contents. The agency typically intervenes only after a problem has been reported, issuing warnings and recalls.
Why This Recall Matters for Public Health
The hidden presence of sildenafil and tadalafil is especially perilous. For the millions of Americans prescribed nitrates for heart conditions, combining these substances can cause a critical and life-threatening drop in blood pressure. This can lead to dizziness, fainting, heart attack, or stroke due to insufficient blood flow to the brain and heart.
Men with diabetes, high blood pressure, or heart disease—who are frequently prescribed nitrates—face the most severe risk from these contaminated products.
The market for such supplements is driven by substantial demand, with an estimated 30 million men in the US experiencing erectile dysfunction. The widespread use of prescription treatments is evident; by 2005, just seven years after Viagra's launch, it had been prescribed to over 23 million men.
The latest recall notice did not specify what prompted StuffbyNainax LLC to initiate the action or whether the contamination was discovered by a consumer or an external laboratory. Consumers in possession of MR.7 SUPER 700000 capsules are urged to stop using them immediately and dispose of the product safely.
