What happened
Original notice title
Thirsty Run LLC / US Royal Honey LLC MARCS-CMS 623359, July 01, 2022
From the archived source record
Based on our review of your websites and laboratory analysis of your products, FDA has identified serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Prohibited Act under Section 301(ll) FDA confirmed through laboratory analysis that samples of your products, Etumax Royal Honey for Him and Dose Vital Honey for Men, contain the undeclared active pharmaceutical ingredient tadalafil, and your product, Secret Miracle Royal Honey for Her, contains the undeclared active pharmaceutical ingredient sildenafil, both of which are phosphodiesterase type-5 (PDE-5) inhibitors. 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 FDA reviewed your websites at www.thirstyrun.com and www.usroyalhoney.com in June 2022 and determined you take orders there for the products Etumax Royal Honey for Him, Dose Vital Honey for Men, and Secret Miracle Royal Honey for Her. This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction. Previous FDA laboratory analyses confirmed that Pink Pussycat contains the undeclared ingredient sildenafil (December 8, 2021 Public Notification: Pink Pussycat contains hidden drug ingredient, [see original source] ).
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
- dc1960f88554
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 →