A California-based company has voluntarily recalled some of its products after they were found to contain “undeclared” pharmaceutical ingredients sildenafil and tadalafil, the FDA said
Credit: FDA
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- Adult novelty company Gear Isle, based in California, has recalled two of its chocolate products after discovering they contained “undeclared” erectile dysfunction drugs, sildenafil and tadalafil, the U.S. Food and Drug Administration (FDA) has said
- The organization warned these ingredients could dangerously interact with certain medications and cause “life-threatening” drops in blood pressure
- Customers are advised to stop using the products and return them for a refund through the company’s website
An adult novelty company based in California is recalling some of its chocolate products after it was discovered they contained potentially harmful amounts of ingredients also found in Viagra.
Gear Isle has voluntarily recalled its Gold Lion Aphrodisiac Chocolate Male Enhancement Sachet and Ilum Sex Chocolate Male Sexual Enhancement Booster after the products were found to contain “undeclared” active pharmaceutical ingredients sildenafil and tadalafil, the U.S. Food and Drug Administration (FDA) announced in a release.
The chocolates are both labeled as dietary supplements and are sold nationwide on Gear Isle’s website.
Sildenafil and tadalafil are similar to phosphodiesterase type 5 (PDE-5) inhibitors that are widely used to treat erectile dysfunction. They slow down or stop the action of the PDE-5 enzyme in the body, increasing blood flow to the penis when aroused, according to the Urologic Surgeons of Washington (USW).
Credit: FDA
“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) and may cause a significant drop in blood pressure that may be life-threatening,” the FDA said.
Sildenafil and tadalafil are especially harmful for men who take nitrates for cardiac conditions, added the organization.
According to the USW, the most common reported side effects of sildenafil and tadalafil include headaches, indigestion and nasal congestion. Tadalafil can cause additional symptoms of back pain and upper respiratory tract infections, while patients taking sildenafil may experience loss of vision in very rare situations.
Gear Isle has not received any reports of adverse effects from the recalled products to date, per the FDA.
Credit: Aleli Dezmen / Getty Images
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The West Sacramento-based company is asking customers who purchased the chocolate to stop using it and return it for a refund.
“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.
PEOPLE has reached out to the FDA and Gear Isle for additional information, but didn't immediately receive a response.
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