Male enhancement capsules - recalled due to undeclared tadalafil & sildenafil, USA

United States

Gear Isle is voluntarily recalling several Male enhancement capsules (Brands: Pro Power Knight Plus, NUX, Dynamite Super) to the consumer level. FDA analysis has found the products to be tainted with sildenafil and tadalafil. Sildenafil and tadalafil are ingredients known as Phosphodiesterase Inhibitors (PDE-5) inhibitors found in FDA-approved products for the treatment of male erectile dysfunction. The presence of sildenafil and tadalafil in these products renders them unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall. The products were distributed Nationwide in the USA via internet sales via the website gearisle.com. To date, Gear Isle has not received any reports of illness or adverse events related to this recall.

The recalled products are:
- Pro Power Knight Plus Capsule, 2550 mg 1-count blister card, UPC: 4 9492290522 0, Expiration date: 06/2026
- NUX Male Enhancement Capsule, 1-count blister card, UPC: 6 0157751236 3, Lot # RO 927996, Expiration date: 12/25/2024
- DYNAMITE SUPER Capsule 58,000 mg 1-count blister card, UPC: 6 7579937602 7, Lot# OMS760-B, Expiration date: 12/2025.

These products are marketed as dietary supplements for male sexual enhancement and are packaged in 1-count blister cards.

Consumption of products with undeclared 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.

Company name: Gadget Island, Inc.
Brand name: Pro Power Knight Plus, NUX, Dynamite Super
Product recalled: Male enhancement capsules
Reason of the recall: Product contains undeclared tadalafil and sildenafil
FDA Recall date: April 26, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gear-isle-issues-voluntary-nationwide-recall-pro-power-knight-plus-nux-male-enhancement-and-dynamite