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Posted May 04, 2023

PrimeZEN Enhancement Supplement for Men Found to Contain Prescription Drug

On April 27, 2023, the FDA issued a warning letter to Tager Online, Inc. DBA Volt Candy; Volt Candy Wholesale Club after FDA laboratory analysis determined PrimeZEN Black 6000, a product promoted to improve sexual function for men, contains tadalafil and sildenafil.

Sildenafil (the active ingredient in Viagra) and tadalafil (the active ingredient in Cialis) are prescribed for erectile dysfunction. 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 statements on the company’s website and social media to be drug claims because products were intended to prevent, treat, or cure disease and/or affect the structure or function or the body. For example, PrimeZEN Black 6000 products were promoted with statements such as, “Stimulates libido and supports normal hormone levels and the quality of sperm as well.”

The FDA also found products to be misbranded because product labeling fails to bear adequate directions for its intended use and lacks proper warnings of the presence of tadalafil or sildenafil for the protection of consumers.

Volt Candy must respond the the agency within 15 days of receipt of the warning explaining the specific steps taken to address any violations.

See ConsumerLab’s Review of Sexual Enhancement Supplements for tests of related products.

For more information, use the link below.

Warning: Tager Online, Inc. DBA Volt Candy; Volt Candy Wholesale Club

See related recalls and warnings:

Male Sexual Enhancement Supplement Adam’s Secret Found to Contain Prescription Medication

Male Sexual Enhancement Supplement Found to Contain Prescription Drug

FDA Warns Consumers Not to Use Male Enhancement Supplement

FDA Warns Sellers of Tainted Honey-Based Sexual Enhancement Products

Honey-Based Enhancement Supplement Recalled