This energy supplement might be sweet, but the latest news about it definitely isn’t.
The FDA announced this week that a Virginia company is voluntarily recalling its honey-based energy support supplement because it may contain a prescription drug commonly used to treat erectile dysfunction.
So far, no adverse health events have been reported, but Akkarco LLC is urging anyone who purchased the product to stop using it immediately.
In its announcement, the FDA labeled the product Ashfiat Alharamain Energy Support as an unapproved new drug, noting that its safety and efficacy have not been established.
The supplement is marketed as a tool to enhance male vitality, improve physical and sexual performance, strengthen the immune system, and boost mental focus.
The recall was triggered after the FDA tested the product and detected Tadalafil, the active ingredient in Cialis. The prescription medication cannot be legally marketed as a dietary supplement and is approved only for use under medical supervision.
“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 Post.
The FDA’s announcement did not specify what led the agency to sample the product, and Tadalafil is not listed on the ingredient label.
Tadalafil — which is sometimes nicknamed the “weekend pill” — can last for up to 36 hours. Viagra, which is also used to treat erectile dysfunction, usually lasts about four hours.
While Tadalafil is FDA-approved, it carries a risk of side effects including cardiovascular complications, blood pressure changes, dizziness, headache, indigestion, nasal congestion and muscle aches.
Those risks increase for people with underlying health conditions or those taking medications that interact with Tadalafil, including nitrates, alpha blockers and protease inhibitors.
For example, combining Tadalafil with nitroglycerin — a fast-acting medication used to prevent chest pain from coronary artery disease — can cause blood pressure to drop to dangerous levels, potentially triggering fainting, shock, heart attacks or even stroke.
What customers need to know
The recall covers a batch of Ashfiat Alharamain Energy Support with lot number ENCOT24, expiring Oct. 2028, packaged in a glass bottle with an orange label.
It was distributed nationwide through online sales on Akkarco’s website and third-party sellers, including Amazon.
“Sales of the affected batch were extremely limited,” the Akkarco spokesperson said.
“The product was sold in very small quantities online via Amazon, and distribution was promptly halted once the issue was identified,” they noted. “Akkarco has since published recall notices and is directly contacting purchasers to facilitate the return of the product.”
Customers who purchased the recalled product are instructed to stop using it immediately and either throw it out or return it to the original seller.
Anyone who experiences an adverse reaction can report it online.
“[Akkarco] is now working toward ensuring that any future distribution is conducted strictly in accordance with prescription requirements and applicable FDA regulations,” the spokesperson said.
