The FDA Just Issued a Recall on a Supplement Drink — Because it Contains an ED Drug
WITHIN THE LAST several weeks, news broke that two supplement companies were voluntarily recalling their products. The reason: The presence of drugs typically found in erectile dysfunction (ED) medication.
(Pause to gasp.)
On Wednesday, Natural Dior, LLC, announced they were recalling the affected lot of their Vitafer-L Gold Liquid drink nationwide, due to undeclared traces of tadalafil, the active drug in Cialis, a popular ED treatment. This drink is marketed as a supplement filled with “essential vitamins and minerals.” In November, the FDA warned against a similar supplement from the same company also due to traces of the same drug.
Last week, another product was recalled for the same issue. One Source Nutrition, Inc., voluntarily removed their Vitality capsules from shelves after finding traces of tadalafil and sildenafil, another ED drug. These capsules were marketed towards “male enhancement.”
Yes, it’s confusing that a supplement marketed for improving sex would have an ED drugs as an ingredient, but know that products containing sildenafil and tadalafil cannot be marketed as dietary supplements, according to the FDA.
Tadalafil and sildenafil are known as phosphodiesterase (PDE-5) inhibitors drugs that open blood vessels to promote blood flow and lower blood pressure. And here’s the danger if you don’t know when you’re consuming them: They can interact with nitrates found in other drugs intended to treat diabetes, high blood pressure, high cholesterol, and heart disease, causing a severe drop in blood pressure that can be fatal.
What’s just as scary is that recalls like these aren’t exactly uncommon. Eight similar recalls happened in 2024. Five occurred in 2023.
And no, the inclusion of these undeclared drugs into supplements is usually not an accident.
When a company manufactures and distributes a dietary supplement, they are responsible for ensuring a product’s quality—by identifying what’s in it, and testing for possible contaminants. Although dietary supplements are regularly tested by the FDA, the manufacturers and distributors of the consumer product are solely responsible for the quality of these products before putting them into commerce. FDA testing often does not happen until after these products have already hit the shelves, due to the vast volume of products on the market.
It’s known that drugs such as tadalafil are intended to address erectile dysfunction. Therefore, it’s not surprising that they would end up as a component in “male enhancement” dietary supplements, says Robert Durkin, former Acting Director and Deputy Director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition.
“To not test for the presence of these types drugs [before putting the supplement on the market] is either turning a blind eye to manufacturing requirements, or letting it be done deliberately,” he says. “Unfortunately, sometimes it’s a company’s business model to do this as long as it can.”
Meaning: Company A will create, or allow, a supplement to be enhanced with ED drugs. They sell it for however long it takes to get caught by the FDA. Once caught, they take the money they earned, and hide out for a few months. Then, they build up Company B, providing a very similar product under a different brand, until they get caught again—if ever, Durkin says. And the cycle continues.
Let this be a healthy reminder: Always speak to your doctor or dietitian before taking any kind of dietary supplement. When you do purchase a supplement, make sure they are manufactured and distributed by reputable companies, and have been tested by a third party, like NSF or Informed Choice. These certifications can help to ensure you’re getting only what’s on the label.
