The FDA has announced an urgent recall of a ‘male enhancement’ supplement after it was discovered the product was tainted with 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 active ingredients in FDA-approved prescription drugs 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 to the same extent that prescription drugs are, with the agency only stepping 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.
MR.7 SUPER 700000 is an unapproved product and safety and efficacy have not been established for it
Taking sildenafil or tadalafil can be dangerous for the millions of Americans 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.
Since men with diabetes, high blood pressure or heart disease are frequently prescribed nitrates, they face the most significant risk from these contaminated products.
FDA warnings about gas station male enhancement supplements are not uncommon.
Since 2012, the agency has issued more than 400 similar public warnings and recalls for various male enhancement supplements with names like Rhino 69 and Man Fuel due to the presence of undeclared and potentially harmful prescription drug ingredients.
The latest recall notice did not say what led StuffbyNainax LLC to initiate the recall or whether it learned of the undeclared ingredients from a consumer or outside lab.
The FDA does not validate the safety and contents of dietary supplements.
In the US, an estimated 30 million men have erectile dysfunction. While precise current numbers for these specific drugs are difficult to determine due to off-label and recreational use, their reach is substantial (stock)
Because these products do not go through a pre-market approval process, the agency does not routinely test them to confirm what is inside. Manufacturers can launch supplements without first informing the FDA.
The affected product does not have lot numbers or expiration dates.
In the US, an estimated 30 million men have erectile dysfunction. While precise current numbers for these specific drugs are difficult to determine due to off-label and recreational use, their reach is substantial.
For perspective, by 2005, just seven years after Viagra’s launch, it had already been prescribed to over 23 million men by more than 750,000 physicians, indicating its massive and rapid adoption.