Safety Report: PrimeZEN Black 6000 male enhancement capsules - recalled due to undeclared ingredients, USA

United States

Volt Candy is voluntarily recalling one lot of PrimeZen Black 6000, 2000 mg capsule, to the consumer level. FDA analysis has found PrimeZen Black 6000 capsules to be tainted with sildenafil & tadalafil. Sildenafil and tadalafil are phosphodiesterase (PDE-5) inhibitors found in FDA-approved products for the treatment of male erectile dysfunction. The presence of sildenafil, tadalafil in PrimeZen Black 6000 capsules renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall. Volt Candy has not received reports of state adverse events or injuries to date. The product was distributed Nationwide to consumers online.

Risk Statement: PrimeZen Black 6000 capsules containing sildenafil and tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life-threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are most at risk from these products.

PrimeZen Black 6000 is marketed as a dietary supplement for male enhancement and is packaged in a blister card with one capsule, UPC code: 728175521891. The affected PrimeZen Black 6000 includes the following lot number [NPINPB 1003] with an expiration date of 08/16/2025. The product can be identified by the card color in black with the name on it PrimeZen Black 6000. See the pictures attached.

Volt Candy is notifying their online customers by email and is arranging for return of all recalled products. Consumers or those with product in their possession should stop using and return the affected product PrimeZen Black 6000, lot number [NPINPB 1003] Expiration date 08/16/2025 to this address: Volt Candy 324 S. Diamond Bar Blvd #212.

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Volt Candy
Brand name: PrimeZEN
Product recalled: PrimeZEN Black 6000 male enhancement capsules
Reason of the recall: Product contains undeclared tadalafil and sildenafil
FDA Recall date: February 13, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/volt-candy-issues-voluntary-nationwide-recall-primezen-black-6000-capsules-due-presence-sildenafil