Gear Isle is voluntarily recalling chocolate products because they have been found to contain undeclared active pharmaceutical ingredients, sildenafil and tadalafil.
The recalled products are: Gold Lion Aphrodisiac Chocolate Sachet, UPC 795847916279, LOT# no lot number, Expires: 06/2027; and ilum Sex Chocolate, UPC 1002448578911, LOT# no lot number, Expires: 12/25/2027.
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. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are most at risk from these products. To date, Gear Isle has not received any reports of adverse events related to this recall.
The product is labeled as a dietary supplement. The products were distributed nationwide via internet sales.
Gear Isle is notifying its customers by notification letter and is arranging for returns and refunds of all recalled products. Consumers who have the products that are being recalled should stop using them.
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.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
