Akkarco LLC of Lorton, Virginia, issued a voluntary recall of its Ashfiat Alharamain Energy Support supplement after the Food and Drug Administration determined the product contains undeclared Tadalafil, a prescription drug ingredient used to treat male erectile dysfunction.
The FDA announced the recall Tuesday, noting that Tadalafil belongs to a family of drugs known as phosphodiesterase (PDE5) inhibitors, which are found in FDA-approved medications for erectile dysfunction treatment. The presence of this undisclosed pharmaceutical ingredient in a dietary supplement marketed as an energy support product violates federal regulations and poses serious health risks.
Tadalafil is the active ingredient in prescription medications like Cialis and requires medical supervision due to its potential interactions with other drugs and health conditions. The drug can cause dangerous drops in blood pressure when combined with nitrate medications commonly prescribed for chest pain or heart problems. Consumers taking these medications could experience life-threatening cardiovascular complications without knowing they are ingesting Tadalafil through the supplement.
The recall affects all lots of Ashfiat Alharamain Energy Support distributed by the Virginia-based company. The FDA has not yet disclosed how the undeclared ingredient was discovered or whether any adverse events have been reported in connection with the product.
Dietary supplements are regulated differently than prescription medications under federal law. While supplement manufacturers are prohibited from adding prescription drug ingredients to their products, enforcement relies heavily on post-market surveillance and testing. The FDA conducts periodic inspections and testing of supplement products, particularly those marketed with claims suggesting pharmaceutical-like effects.
This recall highlights ongoing concerns about the supplement industry's oversight and the potential for products to contain undisclosed pharmaceutical ingredients. The FDA has previously issued warnings about similar products containing hidden drug ingredients, particularly those marketed for sexual enhancement, weight loss, and muscle building.
Consumers who purchased Ashfiat Alharamain Energy Support are advised to stop using the product immediately and consult with healthcare providers if they have experienced any adverse effects. Those taking nitrate medications or who have cardiovascular conditions should seek immediate medical attention if they have used the supplement.
The company has not yet issued a public statement regarding the recall or indicated how customers can return the product for refunds. Federal regulations require companies conducting voluntary recalls to provide clear instructions for product returns and consumer notifications.
This incident underscores the importance of purchasing supplements only from reputable manufacturers and consulting healthcare providers before using products that claim to boost energy or enhance performance. The FDA recommends that consumers be particularly cautious of supplements that promise dramatic results or seem too good to be true.
The recall also raises questions about the supply chain oversight for supplement ingredients and whether adequate testing protocols are in place to detect pharmaceutical adulterants before products reach consumers.
Tadalafil's inclusion in an energy supplement appears particularly concerning given that consumers would have no reason to expect a prescription drug ingredient in such a product. Unlike supplements marketed for sexual enhancement, where consumers might be more aware of potential pharmaceutical ingredients, energy supplements are typically viewed as containing only herbal or nutritional components.
The FDA continues to investigate the source of the Tadalafil contamination and whether other products from Akkarco LLC may be affected. The agency has not indicated whether criminal charges or civil penalties will be pursued in connection with the violation.
Consumers experiencing adverse effects from the recalled supplement should report them to the FDA's MedWatch program, which tracks safety issues with medical products. Healthcare providers are also encouraged to report any suspected adverse events related to dietary supplement use.
This recall serves as a reminder that dietary supplements, while widely available over-the-counter, can contain powerful pharmaceutical ingredients that may interact dangerously with prescription medications or pose risks to individuals with certain health conditions. The incident highlights the need for continued vigilance in supplement safety oversight and consumer education about potential risks.