Ashfiat Alharamain Honey Product for Energy Support recall: Product contains tadalafil

What the company announced

“Press was updated to add the correct batch number.”

Akkarco LLC of Lorton, Virginia, is voluntarily recalling Ashfiat Alharamain Energy Support because the product contains undeclared Tadalafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE5) inhibitors. Products containing tadalafil cannot be marketed as dietary supplements. Ashfiat Alharamain Energy Support is an unapproved new drug for which safety and efficacy have not been established.

Tadalafil is approved by the FDA only for use under medical supervision. Products containing this ingredient without proper authorization may pose potential health risks to consumers, particularly for individuals with underlying medical conditions or those taking certain medications. Possible adverse effects may include, but are not limited to, cardiovascular complications, blood pressure changes, dizziness, headache, and other related symptoms.

The affected product(s) were distributed nationwide within the United States https://akkarco.com/ including third-party e-commerce marketplaces i.e. amazon.com .

The recalled product is packaged in a in a glass bottle with an orange label, and includes the code information below

Product & Brand Name: ASHFIAT ALHARAMAIN

UPC: 1234561870003

Batch No: ENGOT24

EXP: OCT, 2028

Product codes and expiration date scan be found on the product packaging backside.

The recall was initiated after Akkarco LLC was notified by the FDA of the sample results and received confirmation of an FDA online alert https://www.fda.gov/drugs/medication-health-fraud-notifications/ashfiat-alharamain-energy-support-may-be-harmful-due-hidden-drug-ingredient indicating the presence of Tadalafil, a prescription-only substance, in the product.

To date, no confirmed adverse health events have been reported to the Company in connection with the recalled product(s).

Consumers who have purchased the recalled product(s) should:

Stop using the product immediately; and

Follow return or disposal instructions provided by the seller or distributor.

Consumers with questions may contact Akkarco LLC at:

Recall Firm Name: United Legal Experts

Email: [email protected]

Hours: Monday to Friday, 08:00-16:00 EST

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm1

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm2 or call 1800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.