The administration explained that StuffbyNainax LLC initiated a voluntary recall of all batches of MR.7 SUPER 700000 capsules, following test results that revealed the presence of sildenafil and tadalafil, which are prescribed and approved drugs for treating erectile dysfunction, without indicating them on the product label.
These two substances are sold under the trade names “Viagra” and “Revatio” for “sildenafil”, and “Cialis” for “tadalafil”, and fall under the category of phosphodiesterase type 5 (PDE-5) inhibitors, which are not permitted for use in dietary supplements according to the regulations of the Food and Drug Administration.
The FDA confirmed that the product is not approved and its safety or effectiveness has not been proven, noting that dietary supplements are not subject to the same level of control as prescription drugs, as its intervention is often limited to warning or withdrawal after health problems are reported.
The Food and Drug Administration warned of the potential risks of taking these substances without medical supervision, despite their approval as medicines, as they may cause side effects including headaches, indigestion, back and muscle pain, and dizziness.
It stated that the product was distributed on a limited scale within the United States via the internet between August and November 2025.
The administration indicated that the risk increases in people taking medications for chest pain, such as nitroglycerin, as combining it with sildenafil or tadalafil may lead to a sharp drop in blood pressure, which may cause fainting, heart attacks, or strokes.
She added that men with diabetes, high blood pressure, or heart disease are more likely to experience complications, given their frequent use of nitrate derivatives.
The FDA noted that warnings regarding sexual performance enhancement supplements are not new, explaining that since 2012 it has issued more than 400 warnings and recalls of similar products with different brand names, due to their containing undeclared pharmaceutical ingredients.
The latest recall notice did not specify why the violation was discovered, or whether it was the result of a consumer report or independent laboratory tests. It also stated that the product did not have batch numbers or expiry dates.
The FDA concluded by emphasizing that dietary supplements are not subject to prior approval before being marketed, nor are they routinely inspected, which allows them to be put on the market without notifying the administration in advance, despite the potential healt risks they may pose.
