USA LESS is voluntarily recalling all lots of LEOPARD Miracle Honey after FDA analysis found it to be tainted with sildenafil. Sildenafil is an FDA-approved drug for the treatment of male erectile dysfunction. However, the presence of sildenafil renders the honey to be an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
At particular risk are consumers with diabetes, hypertension, high cholesterol or heart disease, who could realize a drop in blood pressure due to conflicts with other medications. To date, USA LESS has not received any reports of adverse events related to this recall.
The manufacturer is notifying customers via e-mail and is arranging for returns. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.