Pure Vitamins and Natural Supplements, LLC announced on March 14 a voluntary nationwide recall of three honey-based products after laboratory analysis by the Food and Drug Administration found undeclared prescription drug ingredients. The affected products are Boner Bear Honey, Red Bull Extreme, and Blue Bull Extreme.
The recall was initiated after FDA testing confirmed that Boner Bear Honey contains both sildenafil and tadalafil, while Red Bull Extreme and Blue Bull Extreme contain sildenafil. These substances are the active ingredients in the prescription drugs Viagra and Cialis, which are approved by the FDA for treating erectile dysfunction under medical supervision. The presence of these drugs in over-the-counter supplements poses health risks because they can interact with nitrates found in some medications used by people with conditions such as diabetes, high blood pressure, high cholesterol, or heart disease. Such interactions may cause dangerously low blood pressure.
The recalled products are marketed as sexual enhancement honey supplements and come in single-serving plastic tubes. Specific lot numbers include Boner Bears Honey lot # BBH0128 EXP 01/28 (UPC code 788362191603), Red Bull Extreme B/N ORB524 MGG Date: MAY 2024 EXP DATE: MAY 2029 (UPC Code 9554100205595), and Blue Bull Extreme EXP Date 02/2029 (UPC Code 707443349917). The product names appear on both the outer packaging and individual serving tubes.
Although Pure Vitamins and Natural Supplements is not the manufacturer of these items, it is conducting the recall voluntarily. The company has notified customers via email to stop using the products immediately and discard them. Consumers who have purchased any of these recalled items are urged to return them to the place of purchase for a full refund including shipping costs. As of now, no adverse events related to this recall have been reported.
Consumers experiencing problems related to these products should contact their healthcare provider. Adverse reactions or quality issues can be reported to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm or by mail or fax using forms available at www.fda.gov/MedWatch/getforms.htm or by calling 1-800-332-1088.
