FitRX, LLC dba Zealthy
FDA issued a warning letter to FitRX, LLC dba Zealthy on September 9, 2025, citing that the company's website (getzealthy.com) made false or misleading claims implying its compounded semaglutide products are equivalent to FDA-approved brand-name drugs Wegovy and Ozempic. The claims violate FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded Zealthy cease the offending language immediately and provide a written corrective response within 15 working days, warning that failure to comply may result in seizure or injunction.
Flagged claims (3)
Is Semaglutide the same as Wegovy and Ozempic? Semaglutide is the active ingredient in Wegovy and Ozempic. Semaglutide is often more cost effective...
Semaglutide is the active ingredient in Wegovy and Ozempic. Semaglutide is often more cost effective for Zealthy members whose insurance deny coverage of brand name medication like Wegovy or who are uninsured.
Your healthcare provider will help you find the right dose of GLP-1 Medication including Semaglutide (same active ingredient as Wegovy, and Ozempic), to achieve healthy weight loss.
Required actions (3)
You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product).
Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance describing the specific steps you have taken to address any violations.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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