Game Changer Products LLC is voluntarily recalling all lots of its 10 Day Forecast capsules to the consumer level, the company said Thursday in an announcement posted by the U.S. Food and Drug Administration. The company said FDA analysis found the product contains undeclared sildenafil and acetaminophen.
Sildenafil is an active ingredient in an FDA-approved prescription drug used to treat erectile dysfunction. Acetaminophen is a drug used to temporarily relieve pain and reduce fever. The company said products containing them cannot be sold as dietary supplements, and that 10 Day Forecast capsules are unapproved new drugs whose safety and effectiveness have not been established.
The company said sildenafil can interact with nitrates, which are found in some prescription drugs such as nitroglycerin. That interaction may sharply lower blood pressure, and the drop may be life threatening. The company said people with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates. It said men who use nitrates for heart conditions are most at risk among the adult men most likely to use the product.
For people who already take acetaminophen, unknowingly taking more may cause life-threatening problems, the company said. These include liver damage ranging from mild problems to complete liver failure and death, as well as anaphylaxis (a severe allergic reaction) and serious skin reactions. The company said it has received no reports of adverse events related to the recall.
The capsules are marketed as a male sexual enhancement product. They come in cards of one or two blue capsules, with the UPC code 191645852717. The packaging has a black background with white lettering. Each card has its lot number and expiration date on the back, and all lots and expiration dates are included.
According to the company, it sold the product nationwide, including in Puerto Rico, Guam and the Northern Mariana Islands. It sold the capsules on eBay and on its own website, gamechangerproductsllc.com, and also supplied one store in Minnesota. The sales ran from at least October 2021 through Oct. 17, 2026. The announcement did not say how many units were sold.
The company said it is emailing customers, contacting eBay buyers through that site’s messaging system, and sending a letter to the retail store. Consumers who have the product should stop using it and throw away unused capsules in a safe manner, the company said. Anyone who has had problems that may be related to the product should contact a physician or health care provider.
Consumers with questions can reach Game Changer Products at 813-419-7033 or mail@gamechangerproductsllc.com, Monday through Friday, 9 a.m. to 6 p.m. Eastern Time. People can report bad reactions or quality problems to the FDA’s MedWatch program online, by mail or by fax. The company said the recall is being conducted with the knowledge of the FDA.