Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.
Violations0
Issue DateJul 1, 2022
Product TypeFood & Beverages
StatusClosed
Closeout LetterFeb 13, 2026
Letter Details
Firm
MKS Enterprise, LLC
Location
Satish Bhatia
MKS Enterprise, LLC
59 Paulison Ave. #13
Passaic , NJ 07055
United States
mks@wholesaleonline1.com
sam77usa@gmail.com
FEI Number
N/A
Country
United States
Issue Date
July 01, 2022
Issuing Office
Center for Food Safety and Applied Nutrition (CFSAN)
Product Type
Food & Beverages
Status
Closed
Closeout Letter
February 13, 2026
Summary
MKS Enterprise, LLC was warned for selling Dose Vital Royal Honey VIP Honey containing the undeclared pharmaceutical ingredient tadalafil (the active ingredient in prescription drug Cialis) through interstate commerce, violating Section 301(ll) of the Federal Food, Drug, and Cosmetic Act. Laboratory analysis confirmed the presence of this PDE-5 inhibitor, which poses serious health risks including dangerous blood pressure drops when combined with nitrates found in common prescription medications used by patients with diabetes, heart disease, and high blood pressure. The company's website and product labeling failed to disclose this active pharmaceutical ingredient, constituting a prohibited act under federal law that restricts adding FDA-approved drugs to food products distributed in interstate commerce.
MKS Enterprise, LLC FDA Warning Letter, July 1, 2022