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Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted January 03, 2024
FDA Warns Amazon for Selling Men’s Supplements Containing Prescription Drugs
Sildenafil (the active ingredient in Viagra) and tadalafil (the active ingredient in Cialis) are prescribed for erectile dysfunction and are not permitted in dietary supplements. These drugs can cause symptoms like headache and flushing and can interact with medications containing nitrates such as nitroglycerine, resulting in dangerously low blood pressure.
In addition, the FDA found many of the products to be unapproved new drugs because products were intended to prevent, treat, or cure disease and/or affect the structure or function of the body. For example, Round 2 products were promoted with statements on the product label such as, “THE POWER TO GO AGAIN! STRENGTH * ENERGY * ENDURANCE.”
The FDA also found MANNERS Energy Boost, Round 2, WeFun, Genergy, Big Guys Male Energy Supplement, and Mens Maximum Energy Supplement products to be misbranded because product labeling failed to bear adequate directions for their intended use and lacked proper warnings of the presence of tadalafil or sildenafil for the protection of consumers.
In August 2023, the FDA warned consumers not to use Big Guys Male Energy Supplement after it was found to contain sildenafil, and in September 2023, WEFUN was recalled.
Amazon.com, Inc. must respond to the agency within 15 days of receipt of the warning explaining the specific steps taken to address any violations.
Consumers and healthcare providers can report any adverse reactions to the FDA’s MedWatch Voluntary Reporting Program.
See ConsumerLab’s Review of Sexual Enhancement Supplements for tests of related products.
Also see: Where to Safely Buy Real Vitamins and Supplements Online, Not Fakes or Counterfeits
For more information, use the link below.
Warning: Amazon.com, Inc.
See related recalls and warnings:
Total Body Nutrition, TBN Labs, and Loud Muscle Science Banned from Selling Adulterated and Misbranded Dietary Supplements
Pain Relief Tea Recalled, Found to Contain Prescription Drugs
Original The Rock Capsules Recalled Due to Undeclared Sildenafil
WEFUN Capsules Recalled Due to Undeclared Sildenafil
FDA Warns Consumers Not to Use Big Guys Male Energy Supplement
Report a Problem
If you have experienced an unexpected and adverse reaction to a dietary supplement, nutritional product, or generic drug, we would like to hear about it, as we may investigate the problem. Please select from one of these options:
Dietary Supplement or Nutritional Product Problem Report
If you believe that a dietary supplement (e.g., vitamin, mineral, or herbal supplement) or other nutritional product has caused an unexpected, adverse reaction, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their Safety Reporting Portal at https://www.safetyreporting.hhs.gov.
Please complete the form below as accurately as possible. You may need to check the label on the product.
Thank you for submitting your report.
Generic Drug Problem Report
If you believe that a generic drug has not acted like the original drug, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their MedWatch program at the FDA MedWatch website.
Please complete the form below as accurately as possible. You may need to check the label on the drug.
Thank you for submitting your report.
