Meta Herbal is initiating a recall of Magnum XXL 9800 2000 mg per capsule due to the detection of undeclared sildenafil in the products. Sildenafil is a phosphodiesterase inhibitor (PDE-5) and is an ingredient found in FDA-approved products designed for treating male erectile dysfunction. Products that contain sildenafil cannot be promoted as dietary supplements. Magnum XXL 9800 capsules are considered an unapproved new drug for which safety and efficacy have not been established, leading to their recall.
Risk Statement: The consumption of products containing undisclosed sildenafil may interact with nitrates present in certain prescription drugs (such as nitroglycerin) and could result in a significant drop in blood pressure, potentially leading to life-threatening situations. Individuals with diabetes, high blood pressure, high cholesterol, or heart disease often use nitrates. Among the adult male population, the primary consumers of this product, adult males using nitrates for cardiac conditions are at the highest risk.
As of now, Meta Herbal has not received any reports of adverse events associated with this recall.