Genesis Health International Inc. dba Genesis
FDA issued a warning letter to Genesis Health International Inc. dba Genesis (Boynton Beach, FL) on February 20, 2026, after reviewing their website trygenesis.com in December 2025. The agency found that Genesis falsely represented itself as the compounder of semaglutide and tirzepatide products by displaying the 'Genesis' name on product labels, and made misleading claims implying FDA approval by stating their products contain 'the same active ingredient as Ozempic® and Wegovy®' and 'Same active ingredient as Mounjaro®.' These practices rendered the products misbranded under FDCA sections 502(a) and 502(bb), and FDA warned that failure to address violations may result in seizure and injunction.
Flagged claims (3)
Contains the same active ingredient as Ozempic® and Wegovy®
Same active ingredient as Mounjaro®
The compounded semaglutide and tirzepatide products displayed on your website identify "Genesis" on the pictured label, suggesting Genesis is the compounder of those drugs when in fact it is not.
Required actions (5)
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.
Addressing the basis for other website claims that could be construed as false or misleading or demonstrating that such claims have been modified or removed in light of FDCA §§ 502(a) and 502(bb)) [21 U.S.C. §§ 352(a) and (bb)].
Identifying the entities that produce the compounded products offered on your website;
Providing a representative sample of labeling for such products;
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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