A honey-based energy supplement, marketed as Ashfiat Alharamain Energy Support, is currently under recall due to the presence of an undeclared prescription-strength medication for erectile dysfunction. The discovery of tadalafil, an active ingredient commonly found in FDA-regulated treatments for male erectile dysfunction, prompted the recall announcement from Akkarco LLC, based in Lorton, Virginia.
Laboratory testing revealed that the product contained tadalafil, which is classified as a phosphodiesterase-5 inhibitor. The U.S. Food and Drug Administration (FDA) stated that dietary supplements are not permitted to include this substance, as its safety and effectiveness have not been evaluated for such use. Products containing tadalafil and marketed without proper authorization are classified as “unapproved new drugs,” meaning they lack the necessary regulatory oversight.
Health officials emphasized the risks associated with consuming tadalafil without medical supervision. Possible side effects include cardiovascular complications, alterations in blood pressure, dizziness, and headaches. These adverse reactions can be particularly concerning for individuals with pre-existing medical conditions or those taking certain medications.
The FDA confirmed that Ashfiat Alharamain Energy Support was distributed nationwide, including through online retailers such as Amazon. The recall specifically affects products packaged in glass bottles with an orange label, identified by batch number ENCOT24 and an expiration date of October 2028. To date, the FDA has not received any reports of adverse events related to this supplement.
Consumers who have purchased the recalled product are urged to discontinue use immediately and consult a healthcare provider if they experience any side effects or health concerns. The FDA encourages individuals to report any related issues through its MedWatch adverse event reporting program.
In response to the situation, Akkarco LLC stated it is working closely with partners and sales platforms to remove all affected products from circulation. The company expressed its commitment to maintaining customer trust and confidence, pledging to implement stringent measures to prevent similar incidents in the future.
