FDA Recall Highlights Ongoing Risks of Adulterated “Sexual Enhancement” Supplements
Pure Vitamins and Natural Supplements, LLC (Tampa, FL) has issued a voluntary nationwide recall of several honey-based dietary supplement products after FDA laboratory testing detected undeclared prescription drug ingredients.
The recalled products include Boner Bear Honey, Red Bull Extreme, and Blue Bull Extreme
According to the company announcement, FDA laboratory analysis confirmed the presence of sildenafil and tadalafil, the active ingredients in the prescription drugs Viagra® and Cialis®, respectively. These medications are approved only for use under the supervision of a licensed healthcare provider for the treatment of erectile dysfunction.
Because the ingredients were not declared on product labeling, the products are considered adulterated and potentially dangerous. Sildenafil and tadalafil can interact with nitrate medications such as nitroglycerin, potentially causing dangerous drops in blood pressure, particularly in patients with cardiovascular disease, diabetes, or hypertension.
The products were marketed as single-serve “sexual enhancement honey” supplements packaged in plastic tubes. No adverse events have been reported to date.
Consumers are advised to discontinue use and return the products for a refund.
Links
Click here to see the recall notice.
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