Safety Report: Your Favorite Shop The Red Pill - recalled due to undeclared Tadalafil, USA

United States

Your Favorite Shop is voluntarily recalling lot # 26436989. Expiry 10/30/2023 of The Red Pill, packaged in 10-count blisters packaged in a carton to the consumer level. The product was distributed via the internet and fulfilled by Amazon at www.amazon.com nationwide in the USA.

Your Favorite Shop was notified by Amazon that laboratory analysis has found the product to be tainted with tadalafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors.

The presence of tadalafil in The Red Pill makes this product an unapproved drug for which the safety and efficacy has not been established and therefore, subject to recall. Consumers with underlying medical issues who take The Red Pill with undeclared tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Your Favorite Shop has not received any reports of adverse events related to this recall.

The product is marketed as a dietary supplement for male sexual enhancement and is packaged in 10-count blisters packaged in a carton, ASIN B0847BSQQ5, the affected lot includes lot # 26436989, Expiry 10/30/2023. The product can be identified by the label below.

On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms. Your Favorite Shop is notifying its customers by this press announcement and sending Amazon messages to its customers and is arranging for return of all recalled products. Consumers that have The Red Pill which is being recalled should stop using the product.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. FDA News Release.

Company name: Your Favorite Shop
Brand name: Your Favorite Shop
Product recalled: The Red Pill
Reason of the recall: Undeclared Tadalafil
FDA Recall date: February 08, 2022

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/your-favorite-shop-issues-voluntary-nationwide-recall-red-pill-capsules-due-presence-undeclared

Source: FDA