Urgent FDA Recall for Contaminated Energy Supplement
The US Food and Drug Administration has issued a critical alert concerning a popular dietary supplement that has been found to contain an undeclared prescription medication. Virginia-based Akkarco LLC is voluntarily recalling its Ashfiat Alharamain Energy Support product after laboratory testing confirmed contamination with Tadalafil, the active ingredient in the erectile dysfunction drug Cialis.
Specific Product Details and Recall Scope
The recall specifically applies to the supplement sold in a distinctive glass bottle with an orange label. Consumers are urged to check the following identifying marks:
- Universal Product Code (UPC): 1234561870003
- Batch Number: ENCOT24
- Expiration Date: October 2028
This product has been available for nationwide purchase and shipping through major online platforms, including Amazon and the company's official website. The FDA initiated the recall after routine sampling and subsequent testing revealed the presence of the undeclared pharmaceutical ingredient.
Significant Health Risks and Regulatory Concerns
Tadalafil is classified as a phosphodiesterase type‑5 (PDE‑5) inhibitor and is strictly regulated as a prescription-only medication. The FDA emphasises that products containing this substance cannot be legally marketed as dietary supplements, which operate under a different regulatory framework with less stringent oversight.
Consuming Tadalafil without proper medical supervision poses substantial health dangers, particularly for individuals with pre-existing conditions. The recall notice highlights several potential adverse effects:
- Cardiovascular complications, including dangerous fluctuations in blood pressure
- Severe headaches and persistent dizziness
- Increased risk of fainting, falls, or more serious cardiac events
These risks are amplified for the millions of Americans taking nitrate medications for chest pain (angina), as combining these drugs with Tadalafil can cause a critical drop in blood pressure, potentially leading to heart attack or stroke.
FDA's Limited Authority Over Supplements
This incident underscores a significant gap in consumer protection. Unlike prescription pharmaceuticals, which undergo rigorous pre-market approval, dietary supplements are not subject to the same level of FDA regulation. The agency typically intervenes only after problems are reported or detected through post-market surveillance, creating a reactive rather than preventative safety system.
The FDA has explicitly stated that Ashfiat Alharamain Energy Support is considered an unapproved new drug, meaning its safety and efficacy have not been established through proper clinical trials. To date, no adverse health events have been reported in connection with this specific recall, but the potential for harm remains high.
Consumer Guidance and Previous Similar Incidents
Customers who have purchased the affected product are strongly advised to:
- Cease using the supplement immediately
- Properly dispose of the product or return it to the point of purchase
- Consult a healthcare professional if they have experienced any unusual symptoms
This is not an isolated case. In December, a similar recall was issued for MR.7 SUPER 700000 capsules, marketed as a male enhancement supplement, which was found to contain both Tadalafil and Sildenafil (the active ingredient in Viagra). That product had been distributed to online customers between August and November 2025, though the specific trigger for that recall remains undisclosed.
The recurring nature of these incidents highlights ongoing challenges in the dietary supplement industry and reinforces the importance of consumer vigilance when purchasing health products, particularly those marketed online with claims of enhanced energy or performance.
