Certain boxes of The Red Pill — male sexual enhancement capsules sold nationwide on Amazon — are being recalled because they may contain a hidden ingredient: an unapproved drug for treatment of male erectile dysfunction.

Jackson, New Jersey-based Your Favorite Shop announced the recall after being “notified by Amazon that laboratory analysis has found the product to be tainted with tadalafil,” according to an announcement posted Tuesday by the U.S. Food and Drug Administration. 

Tadalafil is an ingredient in FDA-approved products for treatment of male erectile dysfunction, and its presence in the Red Pill means the product is an unapproved drug and its safety and efficacy not established, the recall statement said.

People with underlying medical conditions such as diabetes, high blood pressure or heart disease who take the tainted product could have serious health risks, according to the recall announcement. Tadalafil can interact with some prescription drugs, lowering blood pressure to dangerous and possibly life-threatening levels, according to the recall notice.

The recalled product, branded as “The Red Pill That Never Sleeps,” bears the lot number 26436989 and expires on October 30, 2023. 

Your Favorite Shop is sending Amazon messages to customers to arrange for the return of the recalled product. However, calls to the number provided went to a voice mail that had not yet been set up, and a query to the email provided went unanswered. 

It was not clear from the recall notice if there are other lot numbers of the product, and if so whether they are considered safe for people to use. Currently unavailable on Amazon and out of stock on Walmart, the Red Pill is for sale on eBay 

The Red Pill recall comes less than two weeks after a nearly identically worded one for another brand of male sexual enhancement capsules, called Hard Dawn Rise and Shine, also sold on Amazon. That company, Orangevale, California-based Esupplementsales, recalled lot number 2107 with a July 2024 expiration date. The company did not respond to calls and emails.  

The FDA has long cautioned Americans against a multitude of male enhancement or weight loss products found to contain hidden ingredients, saying they can pose “a significant health risk.” 

Despite a decade of warnings, the agency “continues to find potentially dangerous products available for purchase on the internet, including from online marketplaces like Amazon and eBay, as well as in retail stores,” the FDA stated in late 2020.

The FDA in December warned against buying nine potentially dangerous sexual enhancement products from Walmart.com, and in July notified Amazon that its distribution of sexual enhancement and weight loss products violates the federal Food, Drug and Cosmetic Act, according to the agency.

“Walmart takes our customer’s safety very seriously. When the FDA issues recalls, we take immediate action to pull recalled items and block them from being re-added to the assortment, including the ones you mentioned,” a spokesperson for the retailing giant said in an email. 

The FDA and Amazon did not respond to requests for clarification, and eBay did not immediately respond to a request for comment.