What happened
Original notice title
Mihon Corp. d/b/a VitalityVita and Boulla, LLC MARCS-CMS 698165, January 16, 2025
From the archived source record
As described below, these products are unapproved new drugs introduced or delivered for introduction into interstate commerce 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, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352, introduced or delivered for introduction into interstate commerce 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 “VitalityXtra,” 1 “PeakMax,” 2 “ZapMax,” 3 and “ZoomMax,” 4 purchased from your before-noted websites, contain undeclared active pharmaceutical ingredient (API) sildenafil. Additionally, laboratory analyses identified the presence of undeclared API diclofenac in your “PeakMax,” “ZapMax, and “ZoomMax” products. This undeclared API may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products. FDA approved Viagra (containing sildenafil as the active pharmaceutical ingredient) as a new drug on March 27, 1998. Unapproved New Drugs Your “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” 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 for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.
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
- 6df0de0c5281
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.
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