XtraHRD Natural Male Enhancement Capsules by Organic Herbal Supply, Inc.: Recall - Undeclared Drug Ingredient

[Posted 02/22/2017]

AUDIENCE: Consumer

ISSUE: Organic Herbal Supply, Inc. is conducting a voluntary nationwide recall of all lots of XtraHRD Natural Male Enhancement capsules. FDA analysis has found the product to contain Tadalafil. Tadalafil is a FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredients are not listed on the label for this product.

Use of this product may pose a threat to consumers because the undeclared active ingredients 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.

BACKGROUND: XtraHRD Natural Male Enhancement capsules are marketed as a dietary supplement for erectile dysfunction. It is packaged in 2, 4 and 10 count packages and sold nationwide.

RECOMMENDATION: Organic Herbal Supply, advises any customers in possession of the XtraHRD to stop using and return any unused product for a full refund to the company directly. Customers can call 855-429-7328 between the hours of 10 a.m. and 5 p.m. Pacific Standard Time for instructions on the return and refund process. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[02/16/2017 - Press Release - Organic Herbal Supply, Inc.]