Male Enhancement Dietary supplement recalled due to Undeclared Sildenafil and Tadalafil, USA

United States

StuffbyNainax LLC is voluntarily recalling all lots of MR.7 SUPER 700000 capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil, which are active ingredients in FDA-approved prescription drugs used to treat male erectile dysfunction and belong to a class of drugs known as phosphodiesterase type‑5 (PDE‑5) inhibitors. Products containing sildenafil or tadalafil cannot be marketed as dietary supplements. The product was distributed nationwide in the United States to a limited number of online customers between August 2025 and November 2025.

MR.7 SUPER 700000 capsules are considered an unapproved new drug for which safety and efficacy have not been established and are therefore subject to recall.

Risk Statement: Consumption of products containing undeclared sildenafil or tadalafil may cause serious health risks. These ingredients may interact with nitrates found in certain prescription medications (such as nitroglycerin) and may result in a dangerous drop in blood pressure, which can be life‑threatening. Individuals with diabetes, high blood pressure, high cholesterol, or heart disease frequently take nitrates. Adult males who use nitrates for cardiac conditions are at the greatest risk.

Product Description:
The tainted MR.7 SUPER 700000 capsules are marketed as a dietary supplement for male enhancement. The affected product does not have lot numbers or expiration dates.

Affected Product:
- Product Name: MR.7 SUPER 700000
- Brand: MR.7
- Form: Capsules
- Lot Number: Not available / unlisted
- Distribution Period: August 2025 – November 2025
- Distribution: Sold online in the United States

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/stuffbynainax-llc-issues-voluntary-nationwide-recall-mr7-super-700000-dietary-supplement-due