The Partnership for Safe Medicines
SafeMeds Alert
FDA MedWatch Safety Alert
June 22, 2009
Nationwide Recalls of Dietary Supplement Stamina-Rx
Unapproved Ingredient Present in Supplement 
Food and Drug Administration (FDA) and Hi-Tech Pharmaceuticals notified patients and healthcare professionals of a nationwide recall of all product sold under the name Stamina-Rx.  FDA lab analysis found that the product contained the undeclared ingredient − benzamidenafil.  Benzamidenafil is in the same therapeutic class of active pharmaceutical ingredients that are FDA-approved for the treatment of erectile dysfunction (ED).  
Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil 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 and may be most susceptible to adverse effects from this product.
Stamina-Rx is sold predominantly in health food and drug stores nationwide.  Customers who have this product in their possession should stop using it immediately. Any adverse events that may be related to the use of this product should be reported to Hi-Tech Pharmaceuticals, Inc., Norcross, GA 30071 at toll-free 1-888-855-7919 from 9:00 AM - 5:00 PM EST.
The public is encouraged to submit a report of any serious adverse events that occur with the use of Stamina-Rx to FDA's MedWatch Adverse Event Reporting program online at or by phone 1-800-FDA-1088 or by returning the postage paid FDA form 3500, which may be downloaded from by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20853-9787 or fax 1-800-FDA-0178.


Consumer Reports
FDA MedWatch Adverse Event Reporting, 1-800-FDA-1088
Consumer Inquiries
Hi-Tech Pharmaceuticals, Inc., 1-888-855-7971
Media Inquiries
Joseph P. Schilleci, Jr., 205-968-5300
Quick Links 
About the SafeMeds Alert System
As part of the FDA's Alert Network, the SafeMeds Alert System is a free service that sends official alerts from the FDA and other government agencies around the world to anyone-private citizens, public groups, corporations, associations-when specific counterfeit drug incidents occur.

The SafeMeds Alert System is a service of the Partnership for Safe Medicines-a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines.  For more information, please visit