What FDA’s record states
| Field | What FDA’s record states | Source |
|---|---|---|
| Recipient | Kare Solutions, LLC dba Zappy | FDA letter ↗ |
| Location | La Jolla, CA | FDA letter ↗ |
| Letter date | Feb 20, 2026 | FDA letter ↗ |
| Posted by FDA | Mar 3, 2026 | FDA index ↗ |
| Issuing office | Center for Drug Evaluation and Research (CDER) | FDA letter ↗ |
| Subject | False & Misleading Claims/Misbranded (Telehealth) | FDA letter ↗ |
| MARCS-CMS number | 717991 | FDA letter ↗ |
| GLP-1 drugs named | Semaglutide, Tirzepatide, Liraglutide | FDA letter ↗ |
| Response letter | Not published by FDA | FDA letter ↗ |
| Closeout letter | Not published by FDA | FDA letter ↗ |
“The compounded semaglutide, tirzepatide, and liraglutide products displayed on your website identify “Zappy” on the pictured label, suggesting Zappy is the compounder of those drugs when in fact it is not. Accordingly, the representations on your website that Zappy is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].”FDA warning letter to Kare Solutions, LLC dba Zappy, Feb 20, 2026 · read the full letter on fda.gov ↗
What this is and is not.A warning letter is FDA’s statement of what it considers significant violations. It is an allegation, not a court finding, and the firm can respond. A closeout letter is posted when FDA confirms the violations were corrected.
Other GLP-1 letters FDA issued that week
24HrDoc, Inc. dba 24HrDocFeb 20, 2026Alan Health Technologies Inc. dba AlanFeb 20, 2026Aspen Aesthetics dba Fifty 410Feb 20, 2026Belle Health LLC dba BelleFeb 20, 2026Better Health Labs, Inc. dba MeasuredFeb 20, 2026Bliv Wellness LLC dba BlivFeb 20, 2026BluefitMDFeb 20, 2026Deluxe IV Aesthetics PLLC dba Deluxe IV and AestheticsFeb 20, 2026Dripgym Mobile Parent, LLC dba Amp HealthFeb 20, 2026FitRX, LLC dba FitRxFeb 20, 2026Genesis Health International Inc. dba GenesisFeb 20, 2026Good Girl LLC dba GoodGirlRXFeb 20, 2026
And 17 more in the full list.
Source
Every field above is copied from FDA’s page for this letter, read Oct 3, 2026. The letter on fda.gov ↗ · All 161 GLP-1 warning letters