Gear Isle announced on March 26 a voluntary nationwide recall of two chocolate products after they were found to contain undeclared active pharmaceutical ingredients, sildenafil and tadalafil.
The recall affects Gold Lion Aphrodisiac Chocolate Sachet (UPC 795847916279, expiration June 2027) and ilum Sex Chocolate (UPC 1002448578911, expiration December 25, 2027). The company said the products are labeled as dietary supplements and were distributed across the United States through internet sales.
According to Gear Isle, use of these products may pose a health risk because sildenafil and tadalafil can interact with nitrates in some prescription drugs such as nitroglycerin. This interaction could cause a significant drop in blood pressure that may be life-threatening. Adult males who use nitrates for cardiac conditions are considered most at risk. The company said it has not received any reports of adverse events related to this recall so far.
Customers who purchased the recalled items are being notified by letter and offered returns and refunds. Gear Isle advised consumers to stop using the affected products immediately and return them for a refund. For questions about the recall, customers can contact Gear Isle customer service by phone or email during business hours.
Consumers who have experienced problems related to these products are encouraged to contact their physician or healthcare provider. Adverse reactions or quality issues can also be reported directly to the Food and Drug Administration's MedWatch Adverse Event Reporting program online, by mail, or fax. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
