A chocolate-based aphrodisiac item is being pulled from sale after regulators warned it contained dangerously high levels of male enhancement drugs, the Food and Drug Administration (FDA) said.
Gear Isle, a California adult lingerie and sexual wellness retailer, has initiated a voluntary recall after testing found two of its chocolate products contained sildenafil and tadalafil.
Those substances are the generic versions of Viagra and Cialis, medicines commonly prescribed to treat erectile dysfunction and related sexual health conditions. But when taken unknowingly or in excessive amounts, they can create serious health risks.
High doses can drive blood pressure down sharply, which may lead to fainting and, in extreme cases, potentially fatal cardiac events.
The recalled items are the Gold Lion Aphrodisiac Chocolate Male Enhancement Sachet and the Ilum Sex Chocolate Male Sexual Enhancement Booster, which are marketed online in the US through the company’s website.
Rather than being sold as conventional confectionery, the products are labeled as dietary supplements and are provided in powdered form.
In its consumer alert, the FDA said: “Use of products with undeclared active ingredients sildenafil and tadalafil may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin).”
The agency added that this ‘may cause a significant drop in blood pressure that may be life-threatening,’
According to the FDA, the highest risk is for people who use nitrate medications or supplements for heart and cardiovascular conditions. The company has not reported receiving customer complaints to date.
“Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product,” said the FDA.
Gear Isle has also been instructed to notify known purchasers directly, advising them not to consume the affected products. The incident follows a broader pattern of recalls tied to undeclared erectile dysfunction drugs appearing in sexual enhancement items.
The Independent reports that, if you’ll bare with me, ‘Boner Bears Honey’ from Florida’s Pure Vitamins and Natural Supplements LLC, was recalled this earlier month after undisclosed amounts of both sildenafil and tadalafil were found by the FDA.
The same investigation also detected sildenafil in the company’s Red Bull Extreme and Blue Bull Extreme honey-based enhancement products, prompting those items to be removed from sale and returned to the manufacturer.
That followed another recall the previous month involving a different business’s ‘Boner Bears’ product after sildenafil was again detected in the syrup despite not being listed on the label.