Akkarco LLC, based in Lorton, Virginia, has announced a voluntary recall of its Ashfiat Alharamain Energy Support product due to the presence of undeclared Tadalafil. Tadalafil is an active ingredient found in FDA-approved medications for male erectile dysfunction and belongs to the phosphodiesterase (PDE5) inhibitor class. The U.S. Food and Drug Administration (FDA) does not allow products containing Tadalafil to be marketed as dietary supplements, and Ashfiat Alharamain Energy Support is considered an unapproved new drug with unproven safety and efficacy.
Tadalafil is only approved by the FDA for use under medical supervision. Products that contain this ingredient without proper authorization may pose health risks, especially for individuals with pre-existing medical conditions or those taking certain medications. Potential side effects include cardiovascular complications, changes in blood pressure, dizziness, headache, and related symptoms.
The recalled product was distributed nationwide in the United States through various channels including third-party e-commerce platforms such as amazon.com https://akkarco.com/. It comes in a glass bottle with an orange label and can be identified by UPC 1234561870003, batch number ENCOT24, and expiration date October 2028.
Akkarco LLC initiated the recall after being notified by the FDA about sample results confirming the presence of Tadalafil in the product. The FDA also issued an online alert regarding this issue https://www.fda.gov/drugs/medication-healthfraud-notifications/ashfiat-alharamain-energy-support-may-be-harmful-due-hidden-drugingredient.
According to Akkarco LLC, there have been no confirmed reports of adverse health events linked to this product so far.
Consumers who purchased Ashfiat Alharamain Energy Support are advised to stop using it immediately and follow return or disposal instructions from sellers or distributors. Questions can be directed to Akkarco LLC’s recall partner United Legal Experts at office@unitedlegalexperts.com during business hours.
Adverse reactions or quality problems related to this product can be reported to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm1 or by downloading forms from www.fda.gov/MedWatch/getforms.htm2 for submission via mail or fax.
"This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). Akkarco LLC is working closely with its partners and platforms to ensure that all affected products are removed from distribution and sale."
"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."
