Proper Trade LLC/My Stellar Lifestyle voluntarily recalls Wonder Pill capsules, packaged 10-count blisters co-packaged in a carton, and 60-count bottles at the consumer level. Lot 20210912 and lot 31853-501, expiry 09/24 Wonder Pill capsules, contain undeclared Tadalafil.
Tadalafil is a phosphodiesterase type 5 inhibitor indicated for the treatment of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia in men.
Tadalafil is an active ingredient in an FDA-approved drug for Erectile Dysfunction (ED), making Wonder Pill an unapproved new drug. The presence of sildenafil in Wonder Pill renders it an adulterated product under the Federal Food, Drug, and Cosmetic Act.
Amazon notified Proper Trade LLC/My Stellar Lifestyle that laboratory analysis found the products Wonder Pill packaged and labeled as dietary supplements contained Tadalafil.
Amazon also notified the company that these products were not listed with FDA as required by law. This means that they did not adhere to the safety and efficiency of the product hence subjecting it to recall.
Wonder Pill with undeclared tadalafil may expose consumers with underlying conditions to health risks. PDE-5 inhibitors such as tadalafil can interact with other medications that a consumer takes for underlying conditions.
These interactions may cause the consumer’s blood pressure to drop suddenly or irregular heartbeat, which could be fatal. Consumers who take nitrates, such as those with diabetes, high blood pressure, heart disease, or high cholesterol, could experience these dangerous side effects.
Proper Trade LLC/ My Stellar Lifestyle has not received any complaints related to this product to date.
Wonder Pill Overview
Wonder Pill is sold as a dietary supplement for male sexual enhancement. The product is packaged in 10-count blisters, co-packaged in a carton, and sold in a 60-count bottle. The affected lot numbers are 20210912 & 31853-501, Expiry 09/24.
The product is marketed on the internet and through social media. It was also fulfilled by Amazon and Walmart and sold through their marketplace throughout the US.
The United States Food and Drug Administration (FDA) advised consumers on December 17, 2020, not to purchase or use products promoted for sexual enhancement as they contain hidden ingredients.
These products were identified by FDA during an ongoing investigation of dietary supplements. FDA also encouraged online marketplaces not to allow the sale of these products on their platforms.
Proper Trade LLC/ My Stellar Lifestyle has issued a press announcement notifying the public about the FDA’s advisory. The company is also sending messages to Amazon and Walmart not to continue selling the products identified by the FDA and to take appropriate measures to remove these products from their platform. They are currently arranging for the return of the recalled products.
Any consumer who has Wonder Pill should stop using the product immediately and consult a healthcare professional if they have experienced any problems that may be related to taking this supplement.
Consumers with questions regarding this recall can contact Proper Trade LLC at (732)-242-4711 Monday through Friday from 9:00 am to 5:00 pm EST or by email at [email protected].
For any adverse reactions or quality issues, consumers are encouraged to report such incidents to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail, or by fax.
Online: http://www.fda.gov/medwatch/report.htm
Regular Mail: Use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/medwatch/getforms.htm
Fax: 1-800-FDA-0178
This recall is being conducted in cooperation with the FDA.
