FDA Issues Urgent Recall for Honey Energy Supplement Containing Hidden ED Medication
American health authorities have initiated an urgent nationwide recall for a honey-based energy supplement after laboratory analysis discovered it contained an undeclared prescription-strength erectile dysfunction drug. The Food and Drug Administration announced the recall of Ashfiat Alharamain Energy Support on Tuesday following tests that detected tadalafil, an active pharmaceutical ingredient used in FDA-regulated medications for treating male erectile dysfunction.
Undisclosed Pharmaceutical Ingredient Poses Serious Health Risks
The Virginia-based manufacturer Akkarco LLC, operating from Lorton, confirmed it is recalling the product after testing revealed the presence of tadalafil, which was not disclosed on the product's labeling. Tadalafil belongs to the phosphodiesterase-5 inhibitor class of drugs and is strictly prohibited from inclusion in dietary supplements under current regulations.
According to FDA officials, products containing tadalafil that are marketed without proper authorization qualify as "unapproved new drugs" because regulators have never evaluated their safety or effectiveness for consumer use. The agency emphasized that tadalafil is approved only for use under strict medical supervision and can present significant health dangers when consumed unknowingly.
Potential Health Complications and Consumer Warnings
Health authorities have issued specific warnings about the potential side effects of consuming the contaminated supplement. The undisclosed tadalafil may cause:
- Cardiovascular complications and heart issues
- Significant changes in blood pressure
- Severe dizziness and headaches
- Other adverse reactions
These risks are particularly concerning for individuals with pre-existing medical conditions or those taking certain medications that might interact dangerously with the hidden pharmaceutical ingredient.
Product Distribution and Recall Details
The FDA confirmed that the affected product was sold nationwide through various online retailers, including Amazon and other digital marketplaces. The recall specifically covers Ashfiat Alharamain Energy Support packaged in glass bottles with distinctive orange labeling. The affected batch carries the identification number ENCOT24 and has an October 2028 expiration date.
Despite the serious nature of the contamination, the FDA reported that it has not received any adverse event reports linked to the supplement to date. However, officials remain concerned about potential unreported cases and have implemented precautionary measures.
Consumer Guidance and Manufacturer Response
Health authorities are urging consumers who purchased the product to:
- Immediately discontinue use of the supplement
- Consult healthcare providers if they experience any side effects or health concerns
- Report any problems through the FDA's MedWatch adverse event reporting program
In an official statement, Akkarco LLC confirmed it is coordinating with business partners and sales platforms to remove all affected products from distribution channels. The company emphasized its commitment to customer safety, stating: "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."
The incident highlights ongoing concerns about supplement regulation and the potential dangers of undisclosed pharmaceutical ingredients in products marketed as natural health supplements. Consumers are advised to exercise caution when purchasing dietary supplements and to consult healthcare professionals before beginning any new supplement regimen.
