What happened
Original notice title
Shopaax.com MARCS-CMS 626291, July 01, 2022
From the archived source record
Based on laboratory analysis of your product, 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 a sample of your Royal Honey for Him contains the undeclared active pharmaceutical ingredient sildenafil, which is a phosphodiesterase type-5 (PDE-5) inhibitor. This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. 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. It is your responsibility under the FD&C Act to ensure that products marketed by your firm do not contain undeclared ingredients and comply with all requirements of federal law. Please notify FDA in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. Your written reply to the above violations should be directed to Kimberly Dutzek with the FDA via email at CFSANResponse@fda.hhs.gov.
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
- FDA closeout listed
- Source checked
- Jul 16, 2026
- Record revision
- 0219b27c6d2d
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 →