Get.Fit.Medical, LLC dba Get.Fit.Medical

Warning LetterOpen

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

View Letter

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

Violations1

Issue DateSep 9, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Get.Fit.Medical, LLC dba Get.Fit.Medical
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

Get.Fit.Medical sold unapproved and misbranded compounded drugs (sildenafil, tadalafil, semaglutide, and tirzepatide) online by falsely marketing them as "generic" equivalents to FDA-approved products like Viagra, Cialis, Ozempic, and Mounjaro. The company violated the Federal Food, Drug, and Cosmetic Act by making false or misleading claims in product advertising and labeling, implying their compounded products were the same as approved drugs when they are not. The FDA identified these violations during a website review in August 2025 and determined the company unlawfully introduced misbranded drugs into interstate commerce.

Get.Fit.Medical, LLC dba Get.Fit.Medical FDA Warning Letter, September 9, 2025