Warning letter · Center for Drug Evaluation and Research (CDER)
FDA warning letter 721451 to Genesis Health International Inc. dba Genesis
Issued February 20, 2026. The letter alleges that pictured labels identify Genesis as the compounder of semaglutide and tirzepatide products when it is not, and the site claims the same active ingredient as Ozempic, Wegovy and Mounjaro, which the letter calls false or misleading. It asks for a written response and it did not halt the business. The ledger record for Genesis Health passes S8.
The letter, as filed
Every line below is copied from the letter itself. The addressee and the address are the ones the agency prints in the header, which is the pair an attribution rests on.
| Number | MARCS-CMS 721451 |
|---|---|
| Issued | February 20, 2026 |
| Addressee | Genesis Health International Inc. dba Genesis |
| Address | 2500 Quantum Lakes Dr, Boynton Beach, FL 33426 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Subject | False & Misleading Claims/Misbranded (Telehealth) |
| Website reviewed | Genesis Health's website, reviewed in December 2025 |
| Sections cited | 502(a), 502(bb), 301(a), 301(c) of the Federal Food, Drug, and Cosmetic Act |
| Close-out letter | None on the index when the close-out column was last read. |
What it alleges
Pictured labels identify Genesis as the compounder of semaglutide and tirzepatide products when it is not, and the site claims the same active ingredient as Ozempic, Wegovy and Mounjaro, which the letter calls false or misleading.
The letter quotes 2 claims from the website it reviewed, reproduced here exactly as the letter prints them, including the agency's own elisions.
“Contains the same active ingredient as Ozempic® and Wegovy®”
“Same active ingredient as Mounjaro®”
A quoted claim is evidence of what a page said when the agency read it. It is not evidence of what the page says today, and this site records the seller's current pages separately, on the seller record, with their own date.
The sections cited are 502(a), 502(bb), 301(a), 301(c). Section 502(a) makes a drug misbranded where its labeling is false or misleading, and section 502(bb) extends that to the advertising or promotion of a compounded drug. Both are labeling and advertising provisions.
How it was attributed
The entity, street address, reviewed domain and email in the letter match the legal name, footer address and domain the seller prints today; the letter's email is a Genesis Health email address. A letter is filed under an operating entity, and a company may trade under names that appear nowhere in it, so the screen is run against the entity and the address rather than against the brand on the storefront. A name resemblance is never the test, because attaching one company's enforcement record to another is a worse error than missing a disclosure.
What the ledger records since
Genesis Health is recorded against criterion S8, enforcement status as PASS. The basis reads: FDA warning letter 721451, February 2026, names Genesis Health International Inc. dba Genesis at 2500 Quantum Lakes Dr, Boynton Beach, Florida, the address the site prints, and alleges that pictured labels present Genesis as the compounder of its semaglutide and tirzepatide and that claims of the same active ingredient as Ozempic, Wegovy and Mounjaro are false or misleading. No FDA action has halted the business, and the company continues to operate. The storefront was trading as of the date on its record.
The index carries no close-out letter for it. As of September 2026 the index held 3,677 letters and 417 of them carried a close-out letter, so the column is populated and an empty cell is a reading rather than a gap. A letter that has been neither closed out nor followed by an action is the ordinary state of a warning letter.
Why this is not a disqualification
A warning letter identifies a concern, requests a response, and states that failure to address the violations may result in legal action, including seizure and injunction. Those actions are what criterion S8 fails on. The letter is the notice that precedes them and it is not one of them, so this ledger records it in full, dates it, links it, and leaves the seller listed and linked exactly as a seller with no letter.
10 other letters in this ledger carry the same issue date: 717989, to Lean Rx, Inc. dba SkinnyRx, 717991, to Kare Solutions, LLC dba Zappy, 721448, to Strut Health, LLC dba Strut, 721449, to Good Girl LLC dba GoodGirlRX, 721450, to Kin Meds, 721454, to Better Health Labs, Inc. dba Measured, 721478, to Weightless Medical LLC dba WeightCare, 721795, to Belle Health LLC dba Belle, 721814, to Alan Health Technologies Inc. dba Alan, 721816, to Ivim Services LLC dba Ivim.
Sources
- FDA warning letter 721451 to Genesis Health International Inc. dba Genesis, read in full
- FDA, About Warning and Close-Out Letters
- FDA warning letter index, and its close-out column
- The seller record this letter is disclosed on
The letter is quoted from its own page on fda.gov, as it stood on the date in the meta line above. This page ranks nothing, recommends nothing, and carries no partner link.