Ashfiat Alharamain Honey Product for Energy Support recalled due to Tadalafil, USA

United States

Akkarco is voluntarily recalling Ashfiat Alharamain Energy Support because the product contains undeclared Tadalafil, an ingredient in FDA-approved products for the 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. The affected product(s) were distributed nationwide within the United States through their own website and including third-party e-commerce marketplaces i.e. amazon.com.

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

- Product & Brand Name: ASHFIAT ALHARAMAIN
- UPC: 1234561870003
- Batch No: ENCOT24
- 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 indicating the presence of Tadalafil, a prescription-only substance, in the product.

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/akkarco-llc-recalls-product-due-possible-health-risk