Class I — Most Severe

Akkarco Recalls Honey for Undeclared Tadalafil

FreshRecall Team Akkarco LLC Undeclared Drug

This recall was posted 2 months ago. Check the FDA source for the latest status.

Class I Recall — Most Serious

This is a Class I recall — the most serious type. Products covered by this recall may cause serious health consequences or death.

“Image of glass bottle with orange label, Batch No: ENCOT24, EXP: OCT, 2028” “Image of glass bottle with orange label, ASHFIAT ALHARAMAIN ENERGY SUPPORT 250 ml/8 fl. Oz.”

Akkarco LLC has announced a voluntary recall of its Ashfiat Alharamain Energy Support honey product due to the presence of undeclared Tadalafil. This ingredient is typically found in FDA-approved medications for male erectile dysfunction and is not permitted in dietary supplements.

Products Affected:

  • Brand Name: Ashfiat Alharamain
  • UPC: 1234561870003
  • Batch No: ENGOT24
  • Expiration Date: October 2028
  • Packaging: Glass bottle with an orange label

Reason for Recall:

The recall was initiated after the FDA identified Tadalafil in the product, which is only approved for use under medical supervision. The presence of this ingredient poses potential health risks, especially for individuals with underlying health conditions or those on certain medications. Possible side effects include cardiovascular issues, blood pressure changes, dizziness, and headaches.

What Consumers Should Do:

  • Stop using the product immediately.
  • Follow return or disposal instructions from the seller or distributor.
  • Contact Akkarco LLC at [email protected] for further assistance.

No adverse health events have been reported in connection with this recall. Consumers experiencing adverse reactions should report them to the FDA's MedWatch program online or by mail.

Where Products Were Sold

This recall affects products distributed nationwide across the United States.

Contact Information

Media Contact

Shahzaib Amin Malik

Tags

View original FDA announcement