FDA MedWatch - Boner Bears Chocolate by JXK Enterprises

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TOPIC: Boner Bears Chocolate by JXK Enterprises: Recall - Due to Undeclared Sildenafil

AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy, Cardiology

ISSUE: JXK Enterprises is recalling Boner Bears Chocolate, Lot #BB21125, after being notified that FDA laboratory analysis confirmed the presence of sildenafil, an active ingredient in the FDA-approved prescription drug Viagra, which is not declared on the product label.

Sildenafil is approved for use only under the supervision of a licensed healthcare professional for the treatment of erectile dysfunction. Products containing undeclared sildenafil may pose serious health risks. Sildenafil can interact with nitrates found in certain prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Individuals with diabetes, high blood pressure, high cholesterol, or heart disease are at increased risk due to potential interactions.

No other lots or products are included in this recall.

JXK Enterprises has not received any reports of adverse events related to this recall to date.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: Boner Bears Chocolate is marketed as a sexual enhancement product and was distributed nationwide via online sales (https://www.elyxr.com/).

RECOMMENDATIONS: 

• Consumers who have purchased the recalled product are urged to stop using it immediately and contact the company for instructions on return and refund.

• Consumers with questions may contact: JXK Enterprises at (954) 281-2459 or via at email: compliance@elyxr.com.

Health care professionals, consumers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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