FDA MedWatch – ForeverMen by FAonline

TOPIC: ForeverMen by FAonline: Recall – Due Presence of Sildenafil and Tadalafil

AUDIENCE: Consumer, Health Professional, Pharmacy

ISSUE: FAonline is recalling all lots within expiry of the ForeverMen capsules because FDA analysis found these products to be tainted with sildenafil and tadalafil. Sildenafil/tadalafil are FDA approved drugs for the treatment of erectile dysfunction, the presence of sildenafil in the ForeverMen products renders them unapproved drugs for which safety and efficacy have not been established, therefore subject to recall.

Risk Statements: Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that if taken with these products could lower blood pressure to dangerous levels that could be life threatening. 

ForeverMen was distributed to consumers nationwide via the Internet. 

To date, the company has not received any reports of adverse events related to this recall.

For more information about this recall, click on the red button “Read Recall“ below.

BACKGROUND: The product being recalled is marketed as a dietary supplement for male sexual enhancement.

RECOMMENDATIONS: 

• Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

• FAonline INC. is notifying its customers that have the ForeverMen products to stop use and properly discard the product.

• Consumers with questions regarding this recall can contact FAonline INC. at faonline6520@gmail.com.

Health professionals and consumers 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.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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