ED Drug Contamination Prompts Supplement Recall

PORT ST. LUCIE, Fla.—Palo Alto Labs issued a voluntary nationwide recall of its Aspire36 and Aspire Lite dietary supplement products, following FDA test results showing the products contained potentially dangerous erectile dysfunction (ED) drug compounds.

The lab analysis of product samples found aildenafil in trace amounts and dimethyl sildenafil thione (sulfoaildenafil), a purported analog of sildenafil, an FDA-approved drug used as treatment for male ED. Sulfoaildenafil is close in structure to sildenafil and is thought to have a similar pharmacological and adverse event profile. This may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Palo Alto stressed its strict quality control testing protocols did not include a test for the presence of aildenafil or sulfoaildenafil, but it assured consumers this deficiency has been rectified. The company apologized for any inconvenience and expressed its concern for the health of consumers by conducting a voluntary recall action. Management is working closely with the FDA in the recall process and promised to ensure quality and integrity of all its products.

Consumers who have Aspire36 and Aspire Lite in their possession should stop using them immediately. In the event of any adverse side effects due to the consumption of these products, consumers should contact a physician right away. Any adverse events that may be related to the use of these products should be reported to the FDA's MedWatch program. Palo Alto advised consumers can get a full refund of the purchase price by returning any unused Aspire36 and Aspire Lite to the retail location from which it was purchased or to the company directly, if it was purchased as a part of its direct response program. Consumers can call (877) 240-3340 for instructions on the return and refund process.