U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. Resources | Drugs
  4. Information for Consumers and Patients | Drugs
  5. Buying & Using Medicine Safely
  6. Medication Health Fraud
  7. X3 500K GOLD EDITION may be harmful due to hidden drug ingredients
  1. Medication Health Fraud

X3 500K GOLD EDITION may be harmful due to hidden drug ingredients

[12-27-2024] The Food and Drug Administration is advising consumers not to purchase or use X3 500K GOLD EDITION, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores. 

Image of the X3 500K package

FDA laboratory analysis confirmed that X3 500K GOLD EDITION contains tadalafil and sildenafil not listed on the product label. 

Tadalafil and sildenafil are the active ingredients in the FDA-approved prescription drugs Cialis and Viagra, respectively, used to treat erectile dysfunction. FDA approval of Cialis and Viagra is restricted to use under the supervision of a licensed health care professional. These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Health care professionals and consumers should report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Note: This notification is to inform the public of products potentially marketed as dietary supplements or conventional foods with hidden drug ingredients and chemicals. These products are typically promoted for sexual enhancement, weight loss, pain relief and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.

Please refer to the links below for more information:

Back to Top