A honey-based energy supplement is being recalled due to the presence of an undeclared prescription-strength erectile dysfunction medication. Virginia-based company Akkarco LLC announced the recall of its Ashfiat Alharamain Energy Support product after laboratory tests confirmed the presence of tadalafil, an active ingredient typically used in FDA-regulated medications for treating erectile dysfunction.
The U.S. Food and Drug Administration (FDA) noted that the presence of tadalafil was not disclosed on the product’s labeling, which raises significant health concerns. Tadalafil is classified as a phosphodiesterase-5 inhibitor, and its inclusion in dietary supplements is prohibited. According to the FDA, products that contain tadalafil and are marketed without proper authorization are classified as “unapproved new drugs.” This classification indicates that such products have not undergone evaluation for safety or effectiveness by regulators.
Health officials have warned that tadalafil should only be used under medical supervision. The drug can lead to serious health risks if taken unknowingly, including cardiovascular complications, fluctuations in blood pressure, dizziness, and headaches. These risks are particularly pronounced for individuals with pre-existing medical conditions or those who are taking certain medications.
The affected product was distributed nationwide through various online retailers, including Amazon. The recall specifically pertains to Ashfiat Alharamain Energy Support packaged in a glass bottle with an orange label, identified by batch number ENCOT24 and an expiration date of October 2028. As of now, the FDA has not received any reports linking the supplement to adverse health events.
Consumers who have purchased this product are strongly advised to cease use immediately and consult a healthcare provider if they experience any concerning side effects. The FDA encourages individuals to report any health issues through its MedWatch adverse event reporting program.
In its statement, Akkarco LLC emphasized its commitment to customer safety and trust. The company is coordinating with partners and sales platforms to ensure the removal of all affected products from distribution. “Akkarco LLC is committed to upholding the trust and confidence of its customers and will continue to implement stringent measures to prevent such incidents in the future,” the company stated.
In light of this incident, consumers are reminded to be vigilant when purchasing dietary supplements, ensuring that products are properly labeled and approved for safety.
