A Texas-based company is voluntarily recalling all lots of AMPT Coffee after analysis from the U.S. Food and Drug Administration (FDA) found the presence of undeclared milk and drugs sildenafil and tadalafil, the active ingredients for erectile dysfunction medications Viagra and Cialis respectively.
The Aug. 1 announcement from the FDA warned that the drugs in the coffee can be dangerous to some men.
“These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels,” the FDA said. “Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.”
Undeclared milk can result in serious or life-threatening allergic reactions in some people, the FDA also warned.
The recalled products from AMPT Life were sold online through the company’s website between April 2016 and March 2017, and were marketed as “a natural alternative to testosterone therapy.” AMPT Coffee was marketed as a libido-boosting instant coffee and retailed for $89.99 for 10 individual packets.
No injuries have been reported, but consumers with the products are being asked to stop using and discard any remaining AMPT Coffee products.
FDA Targeting OTC Male Enhancement Products
This marks the third time in the last few months that instant coffee products have been recalled due to the presence of undeclared drugs.
In July, Bestherbs Coffee LLC announced the recall of its New of Kopi Jantan Tradisional Natural Herbs Coffee after the FDA confirmed the presence of desmethyl carbodenafil, a drug structurally similar to sildenafil.
Two months before that recall, Caverflo voluntarily recalled all of its Caverflo Natural Herbal Coffee after similar findings of sildenafil and tadalafil in the product. Unlike the other two recalls, Caverflo received a report of one death associated with coffee. No additional information about the death was released to the public.
Albert Yee, the owner of Bestherbs Coffee, told The Washington Post that he suspects the ingredient Tongkat Ali was the source of the problem. The tree root is found in Malaysia and often used in natural remedies but can be expensive and difficult to harvest.
Yee suggested the producers of his coffee and similar products may have added erectile dysfunction drugs to cut down on costs.
The president of Stiff Bull, whose herbal coffee was recalled last year over similar findings, also said manufacturers in Malaysia used the drugs without his knowledge to cut costs.
The FDA began looking further into the hidden ingredients inside tainted sexual enhancement products last year after it identified an emerging trend of over-the-counter products containing potentially harmful active ingredients not on the label.
In 2013, the FDA began warning the public that over-the-counter male enhancement products may contain the active ingredients of Viagra and Cialis. Independent testing from the agency found the undisclosed ingredients in at least two products.
“FDA has identified an emerging trend where over-the-counter products, frequently represented as dietary supplements, contain hidden active ingredients that could be harmful,” the FDA warned. “Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients.”
Since then, the FDA has issued warnings and recalls of several over-the-counter products claiming to be libido boosters.