What happened
Original notice title
Gadget Island, Inc. MARCS-CMS 658733, July 21, 2023
From the archived source record
As described below, these products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, your “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352, and sold in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a). FDA confirmed through laboratory analyses that samples of your “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products each contain the undeclared pharmaceutical ingredients tadalafil and sildenafil. These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Unapproved New Drugs Your “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products are drugs as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1), because they are intended to prevent, treat, or cure disease conditions and/or affect the structure or function of the body. Misbranded Drugs Your “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products are also misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use. Each of your “NUX Male Enhancement,” “DYNAMITE Male Sexual Enhancement,” and “ProPower Knight Plus 2550mg” products, which contain undeclared tadalafil and sildenafil, are also prescription drugs as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. 353(b)(1)(A), in light of their toxicity or potential for harmful effects, methods of use, or collateral measures necessary for their use.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 482efee2a792
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →