FDA WARNING_LETTER - Dripgym Mobile Parent, LLC dba Amp Health - December 31, 2025

The FDA issued a Warning Letter to Dripgym Mobile Parent, LLC, operating as Amp Health, on February 20, 2026, following a December 2025 review of their website, myamphealth.com. The letter addresses significant violations concerning the promotion and sale of compounded semaglutide and tirzepatide drug products. The primary issues identified were false and misleading claims that misbrand the products. Amp Health"s website labels depicted the company as the compounder of these drugs, which the FDA states is false. Furthermore, the website made claims implying FDA approval or evaluation by stating the compounded products contained the "same active ingredient" as FDA-approved drugs like Wegovy®, Ozempic®, Mounjaro®, and Zepbound®. Compounded drugs are not FDA-approved, making these claims misleading regarding safety and effectiveness. These violations constitute misbranding under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), and the introduction of such products into interstate commerce violates section 301(a) of the FDCA. Amp Health is required to provide a written response within fifteen working days. This response must detail specific corrective actions, including identifying the actual entities that produce the compounded products, supplying representative product labeling, and modifying or removing all false or misleading website claims to ensure compliance with federal law. Failure to act may lead to legal consequences.