FDA Recalls Honey Supplement Due To Erectile Dysfunction Drug Inside

The Food and Drug Administration

The Food and Drug Administration recalled a honey energy supplement on Wednesday after an undeclared erectile dysfunction medication was found in the product, the agency said.

Ashfiat Alharamain Energy Support, a product sold as a honey-based, male sexual enhancement supplement, was voluntarily recalled by its manufacturer “because the product contains undeclared Tadalafil, an ingredient in FDA-approved products for treatment of male erectile dysfunction,” the agency said in a statement.

The recall was initiated after a previous notification from the FDA of sample results that showed the presence of the prescription-only substance. The agency warned consumers not to buy the product in October, noting it contained “the active ingredient in Cialis.”

“Ashfiat Alharamain Energy Support is an unapproved new drug for which safety and efficacy have not been established,” read FDA’s Wednesday recall statement, later noting that “no confirmed adverse health events have been reported to the Company in connection with the recalled product(s).”

The honey supplement was previously sold on Amazon and distributed nationwide within the U.S.

“Akkarco’s internal review and subsequent testing confirmed that the quantity present was minimal. Nevertheless, Akkarco takes regulatory compliance seriously and has ceased non-prescription sales of the product,” a spokesperson for the company told The New York Post, noting that “sales of the affected batch were extremely limited.”

Customers who purchased the recalled product were instructed to stop use immediately and consult a medical professional. Adverse reactions can be reported online.

The FDA has announced similar warnings and recalls for supplements in the past due to the presence of undisclosed Tadalafil or other similar ingredients. Many of these supplements were marketed as an aid for male enhancement or sexual performance.

A 2018 study in the journal JAMA found that the agency identified 746 dietary supplements containing undisclosed pharmaceuticals between 2007 and 2016. Nearly half of these products were marketed for sexual enhancement.

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