A Tampa, Florida-based supplement distributor is pulling three honey-based sexual enhancement products off the market after federal laboratory testing revealed they contained hidden prescription drug ingredients.
In a Saturday
notice, the Food and Drug Administration (FDA) announced the recall due to the undeclared ingredients including the active compounds found in Viagra and Cialis—that were never listed on the label.
Pure Vitamins and Natural Supplements, LLC announced the voluntary recall March 14, covering its Boner Bear Honey, Red Bull Extreme and Blue Bull Extreme products. The U.S. Food and Drug Administration confirmed that Boner Bear Honey contained both sildenafil and tadalafil, while Red Bull Extreme and Blue Bull Extreme each contained sildenafil—none of which were disclosed to consumers.
The recall affects specific lot numbers: Boner Bears Honey, lot No. BBH0128, expiration date 01/28, UPC code 788362191603; Red Bull Extreme, batch No. ORB524, manufactured May 2024, expiration date May 2029, UPC code 9554100205595; and Blue Bull Extreme, expiration date 02/2029, UPC code 707443349917. The products are packaged as single-serving plastic tubes and are identifiable by their brand names on the outer box and individual tubes.
Sildenafil is the active ingredient in Viagra, the FDA-approved prescription medication widely used to treat erectile dysfunction. According to the National Institutes of Health's
MedlinePlus, sildenafil works by increasing blood flow to the penis during sexual stimulation, and is also prescribed under the brand names Liqrev and Revatio to treat pulmonary arterial hypertension—a serious form of high blood pressure in the lungs.
Tadalafil is the active ingredient in Cialis. According to the
Mayo Clinic, tadalafil belongs to a class of medications called phosphodiesterase 5 (PDE5) inhibitors, and can maintain an erection by controlling an enzyme that affects blood flow to the penis. Like sildenafil, tadalafil also carries FDA approval for treating pulmonary arterial hypertension, as well as benign prostatic hyperplasia.
Both drugs are available only by prescription and are approved for use exclusively under the supervision of a licensed healthcare professional.
Safety Concerns
The hidden ingredients raise serious safety concerns, especially for consumers who may be taking other medications.According to the FDA, both sildenafil and tadalafil can interact dangerously with nitrates—a class of drugs commonly prescribed for chest pain and heart conditions—including nitroglycerin, isosorbide dinitrate and isosorbide mononitrate. When combined, the interaction can cause a sudden and potentially life-threatening drop in blood pressure.
The
Mayo Clinic warns that tadalafil should never be used alongside nitrate medications, including street drugs known as "poppers" such as amyl nitrate or butyl nitrate, which also contain nitrates. According to
MedlinePlus, anyone needing emergency cardiac care must inform medical personnel when they last took sildenafil, as the timing is critical for safe treatment.
Those who are most at risk—people with diabetes, high blood pressure, high cholesterol and heart disease—are precisely those most likely to already be on nitrate-based medications, the FDA notes.
Beyond the nitrate interaction, both drugs carry a range of potential serious side effects, including sudden vision loss, sudden hearing loss, irregular heartbeat, dangerously prolonged erections, stroke and in rare cases, sudden cardiac death.
What Consumers Should Do
Pure Vitamins and Natural Supplements said it is not the manufacturer of the recalled products but is voluntarily issuing the recall and notifying customers by email. The company is urging anyone who purchased these products to immediately stop using them, discard them and return them to the point of purchase for a full refund, including shipping costs.The company has not received any reports of adverse events linked to the recalled products as of the announcement date.
Consumers with questions can reach Pure Vitamins and Natural Supplements at 1-800-362-4772 or
[email protected], Monday through Friday, 9 a.m. to 4:30 p.m. EST.
Anyone who has experienced health problems they believe may be connected to these products is encouraged to contact their physician and can file a report with the FDA's MedWatch Adverse Event Reporting Program online at
www.fda.gov/medwatch/report.htm, or by calling 1-800-332-1088.
