Brian Richardson, doing business as “In Tha Pink,” is recalling lots of 13-gram packages of the ground “Kopi Jantan Tradisional Natural Herbs Coffee” with the expiration of October 13, 2020, to the consumer level, after FDA laboratory analysis confirmed the presence Sildenafil and Tadalafil. Sildenafil and Tadalafil are FDA approved drugs for the treatment of male erectile dysfunction. Active ingredients in Viagra and Cialis, Sildenafil and Tadalafil can be deadly when combined with nitrates frequently found in heart and blood pressure medications.

The recall comes two years after the Food and Drug Administration posted a public notice on July 13, 2017, warning against the same product, reporting it found desmethyl carbodenafil in the beverage mix, which is marketed as a male enhancement product. Bestherbs Coffee LLC also previously distributed this product from July 2014 through June 2016, noted in an Aug. 30, 2016 warning.

No illnesses had been confirmed in relation to the ground “Kopi Jantan Tradisional Natural Herbs Coffee” product as of the posting of April 8 recall on Monday. However, in May 2017 a recall notice of a similar product by Caverflo.com reported one death.

The undeclared Sildenafil and Tadalafil in the coffee could interact with nitrates in other prescription drugs, such as nitroglycerin. It is common for men with diabetes, high blood pressure, high cholesterol or heart disease to be prescribed nitrates. The undeclared drug could lower blood pressure to dangerous levels.

According to the recall notice, “The product is marketed as a dietary supplement for sexual enhancement and sold in individual 13-gram packages.” There is concern consumers may have unused portions of the recalled 13-gram, red packs in their homes. To determine if they have the recalled product, consumers should check the individual packet for the UPC number “9 557205 06008 3” with an expiration date of “13/10/2020” (October 13, 2020) stamped on the back of the package.

“The recalled Kopi Jantan Tradisional Natural Herbs Coffee was distributed nationwide in the USA by online retail sites, including but not limited to eBay and through mail orders, since September 2017,” the recall said.

Although no illness has been reported to date, the FDA reported that “In Tha Pink” is notifying its customers by mail and arranging for return of all recall products. Consumers or retailers that have the recalled product should stop using it and return the product to “In Tha Pink” for a full refund.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of such products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online at MedWatch online Voluntary Reporting Form, or;

Download and complete the form, then submit it via fax at 1-800-FDA-0178.

In its warning notices, the FDA reported “a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals.”

“These products are typically promoted for sexual enhancement, weight loss, and bodybuilding and are often represented as being ‘all natural.’ FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients,” according to the FDA’s notices warning against the coffee products.