FDA recalls tainted male enhancement supplement after tests find undeclared ED drugs

The FDA has issued an urgent recall of MR.7 SUPER 700000, a dietary supplement marketed as a male enhancement product, after laboratory tests found undeclared erectile dysfunction drugs sildenafil and tadalafil in the capsules.

StuffbyNainax LLC is voluntarily recalling all lots of MR.7 SUPER 700000 after testing revealed the presence of sildenafil and tadalafil. The product was distributed nationwide to online customers between August 2025 and November 2025.

Sildenafil and tadalafil are PDE-5 inhibitors used in prescription medications for erectile dysfunction. They are not permitted in dietary supplements, and the FDA notes that products containing sildenafil or tadalafil cannot be marketed as dietary supplements. The MR.7 SUPER 700000 product is described as unapproved, with no established safety or efficacy.

The FDA emphasizes that it does not regulate dietary supplements to the same extent as prescription drugs. Pre-market testing is not required for supplements, and manufacturers can launch products without FDA validation. In this case, the product does not carry lot numbers or expiration dates. The agency has warned that taking sildenafil or tadalafil carries notable side effects, including headache, indigestion, back pain, muscle aches and dizziness. The risk heightens for people who already take medications to treat chest pain, such as nitrates. Combining PDE-5 inhibitors with nitrates can cause a dangerous drop in blood pressure, potentially leading to dizziness, fainting, falls, heart attack or stroke due to insufficient blood flow to the brain and heart.

The most at-risk populations include individuals with diabetes, high blood pressure or heart disease who are commonly prescribed nitrates. FDA warnings about adulterated male enhancement supplements are not uncommon; since 2012, the agency has issued more than 400 warnings and recalls for products with undeclared or potentially harmful prescription-drug ingredients, including brands like Rhino 69 and Man Fuel. The latest recall notice did not specify what led StuffbyNainax LLC to initiate the recall or whether the company learned of the undeclared ingredients from a consumer or an outside laboratory.

The recall underscores ongoing concerns about the oversight of dietary supplements marketed for sexual enhancement. In the United States, an estimated 30 million men have erectile dysfunction, a figure that reflects broad demand for ED-related products. While precise current numbers for these drugs are complicated by off-label and recreational use, the reach of sildenafil and tadalafil remains substantial. By some measures, Viagra’s rapid adoption in the mid-2000s demonstrated the market’s strong demand for ED treatments, a context that has persisted into the present.

For consumers who purchased MR.7 SUPER 700000, the FDA advises discontinuing use and disposing of the product. Those who have taken the supplement and have concerns or experience adverse effects should consult a healthcare provider. The agency continues to monitor the situation and notes that the lack of pre-market FDA validation for dietary supplements means consumers must rely on product labeling and post-market warnings for safety information.