Vitals RX

Warning LetterOpen

United StatesIssued Sep 9, 2025Center for Drug Evaluation and Research (CDER)

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Letter Details

Firm: Vitals RX
Location: United States
FEI Number: N/A
Country: United States
Issue Date: September 09, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Vitals RX was cited for unlawfully selling unapproved and misbranded compounded drugs, specifically semaglutide and tirzepatide products, over the internet to U.S. consumers. The company's website marketing claimed "Semaglutide/Tirzepatide/Ozempic Weight Loss Clinic," falsely implying its compounded products were equivalent to FDA-approved drugs, violating the Federal Food, Drug, and Cosmetic Act sections 502(a) and 502(bb). The FDA determined these products were misbranded because compounded drugs are not FDA-approved, and the company's claims created a misleading impression that its products held the same status as approved alternatives.