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Safety Report: ForeverMen Natural Energy Boost - recalled due to undeclared allergens, USA

2 months ago source fda.gov

Recall notice

United States

FAonline INC, is voluntarily recalling all lots within expiry of the ForeverMen capsules to the consumer level. FDA analysis founds these products to be tainted with sildenafil and Tadalafil. Sildenafil/Tadalafil is an FDA approved drug 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, therefor subject to recall. ForeverMen was distributed to consumers nationwide via the Internet. To date, Happy Together Inc. has not received any reports of adverse events related to this 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. The products affected are men with diabetes, high blood pressure, high cholesterol, or heart disease.

The product is marketed as dietary supplements for male sexual enhancement and is packaged in a blister card. 10 count box. We are notifying the public through this public announcement due to lack of ability to identify customers who may have received the product. FAonline INC. is notifying its customers that have the ForeverMen products to stop use and properly discard the product.

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.

In case you experienced harm from allergens or undeclared ingredients, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: FAonline Inc
Brand name: ForeverMen
Product recalled: Natural Energy Boost
Reason of the recall: Product is tainted with sildenafil and tadalafil
FDA Recall date: April 02, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/forevermen-supplements-recalled

#dietarysupplements #allergicreaction #recall #us #allergen

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