Warning letter · Center for Drug Evaluation and Research (CDER)
FDA warning letter 721475 to Refills Health, LLC dba Refills Health
Issued February 20, 2026. The letter alleges that pictured labels identify Refills Health as the compounder of semaglutide products when it is not, and claims such as clinically proven and the same active ingredient found in certain FDA approved treatments imply the compounded products have been FDA-approved when they have not. It asks for a written response and it did not halt the business. The ledger record for Refills 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 721475 |
|---|---|
| Issued | February 20, 2026 |
| Addressee | Refills Health, LLC dba Refills Health |
| Address | 1401 Pennsylvania Ave, Suite 105, Wilmington, DE 19806 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Subject | False & Misleading Claims/Misbranded (Telehealth) |
| Website reviewed | Refills' 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 Refills Health as the compounder of semaglutide products when it is not, and claims such as clinically proven and the same active ingredient found in certain FDA approved treatments imply the compounded products have been FDA-approved when they have not.
The letter quotes 2 claims from the website it reviewed, reproduced here exactly as the letter prints them, including the agency's own elisions.
“clinically proven”
“the same active ingredient found in certain FDA approved treatments”
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 letter names Refills' website as the website it reviewed and gives a contact address at that domain, and its entity and Wilmington street address are the ones the seller's contact page, privacy policy and terms print. 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
Refills is recorded against criterion S8, enforcement status as PASS. The basis reads: FDA warning letter 721475, February 2026, names Refills Health, LLC dba Refills Health at the Wilmington, Delaware address the site prints, alleging that pictured labels presented Refills Health as the compounder of its semaglutide and that claims such as clinically proven and the same active ingredient found in certain FDA approved treatments implied FDA approval. No close-out letter appears in the index. No FDA action has halted the business, and the seller still trades. 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.
19 other letters in this ledger carry the same issue date: 717985, to Zeuss LLC dba Zeuss, 717987, to FitRX, LLC dba FitRx, 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, 721451, to Genesis Health International Inc. dba Genesis, 721453, to MaxLife Technologies Inc. dba Maxlife, 721454, to Better Health Labs, Inc. dba Measured, 721455, to MEDVi, LLC dba MEDVi, 721472, to NewSelf Limited dba NewSelf, 721474, to Premium Health Management Inc. dba Premium Health, 721478, to Weightless Medical LLC dba WeightCare, 721479, to Bliv Wellness LLC dba Bliv, 721481, to Aspen Aesthetics dba Fifty 410, 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 721475 to Refills Health, LLC dba Refills Health, 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.