Male Sexual Enhancement Pills Recalled Over Potential to Kill Certain Men

Hundreds of bottles of a male sexual enhancement pill have been recalled due to containing an ingredient that can pose health risks.

The U.S. Food and Drug Administration announced on Wednesday that 500 blister packs of Magnum XXL 9800 manufactured by the company Meta Herbal were voluntarily recalled due to the product being tainted with sildenafil, an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) typically found in FDA-approved products for the treatment of male erectile dysfunction.

The FDA in its announcement stipulates that products containing sildenafil cannot be marketed as dietary supplements. The safety and efficacy of the new drug, which comes as one pill in one package, has not been established and makes it subject to recall.

People who consume products with undeclared sildenafil may interact with nitrates found in some prescription drugs, such as nitroglycerin, and can lead to a significant decrease in blood pressure deemed potentially life-threatening. Those especially susceptible are people with diabetes, high blood pressure, high cholesterol or heart disease who routinely take nitrates.

Among the adult male population most likely to use this product, the FDA says that adult males who use nitrates for cardiac conditions are most at risk. To date, Meta Herbal has not received any reports of adverse events related to this recall.

Newsweek reached out to the FDA and Meta Herbal via email for comment.

Male enhancement products not subject to usual FDA scrutiny

The Magnum XXL 9800 packaging refers to the capsule as a 100 percent herbal extract that will improve one’s prostate and increase the time of sexual intercourse, “size and hardness,” and stamina and sex drive. It states that users will have no headaches or side effects.

The 2000 milligrams per capsule includes a mix of supplements, including saw palmetto, ginseng, wild yam, raspberry and epimedium. An individual is instructed to take the capsule 30 minutes prior to sexual activity and accompanied by water. Users should not take more than one capsule in a 60-hour period.

Packaging also notes that the FDA did not evaluate the company’s statements regarding safety or efficacy.

Sexual enhancement pills don’t receive the same FDA scrutiny as over-the-counter or prescription medications because they are advertised as dietary supplements, according to licensed professionals on the telehealth website Hims.

At least as of February, no “male enhancement” or “sexual enhancement” pills had been approved by the FDA. Companies often circumnavigate FDA requirements and clinical trials by marketing such products as herbal health and dietary supplements that can help with issues pertaining to erectile dysfunction, penis size or general sexual pleasure.

Some pills promise users a strengthened sex drive and healthier blood flow, but the vague advertising has resulted in innumerable male enhancement products being recalled by the FDA in recent years—some of which are routinely on sale at gas stations, sex shops, and through the general online marketplace.

The FDA continually updates a current 42-page list of male sexual enhancement and energy products dating back to May 2012, noting which products contain hidden ingredients.

The administration previously issued consumer warnings of in-store and online retailers like Walmart, Amazon and eBay selling more than 50 such products without proper FDA guidance that contain active pharmaceutical ingredients not listed on their labels—including some with ingredients found in prescription drugs.

In 2018, the FDA warned against using Rhino enhancement products for similar reasons following a spike in health issues including chest pains and prolonged erections among those who consumed that product.

Meta Herbal is notifying its customers via Amazon about the recall and arranging for refunds of all Magnum XXL 9800 packs. People are encouraged to stop using the product and email [email protected] for returns/refunds.