FDA Warning Letters Tracker (GLP-1)
Every FDA warning letter that mentions semaglutide, tirzepatide, or another GLP-1 receptor agonist since January 2022. Sourced directly from FDA’s public warning-letters index. Updated weekly.
3 letters tracked. Last refresh: May 27, 2026.
September 2025 (3 letters)
| Issued | Recipient | Subject | GLP-1 terms | FDA | Cite |
|---|---|---|---|---|---|
| Sep 9, 2025 | Hims & Hers Health, Inc. dba Hims# Center for Drug Evaluation and Research (CDER) | Unapproved Drugs / Misleading Marketing of Compounded GLP-1 | ozempicsemaglutidewegovy+3 | FDA → | |
| Sep 9, 2025 | Hims & Hers Health, Inc. dba Hers# Center for Drug Evaluation and Research (CDER) | Unapproved Drugs / Misleading Marketing of Compounded GLP-1 | ozempicsemaglutidewegovy+3 | FDA → | |
| Sep 9, 2025 | GLP-1 Solution# Center for Drug Evaluation and Research (CDER) | Unapproved Drugs / Compounded GLP-1 Marketing | ozempicmounjarosemaglutide+6 | FDA → |
Methodology
Every Monday at 06:00 UTC, an automated job paginates FDA’s warning-letters index, identifies letters likely to reference a GLP-1 product (recipient name, drug-related subject, CDER issuing office), fetches each candidate, searches the letter body for any of the keywords semaglutide, tirzepatide, liraglutide, retatrutide, Wegovy, Ozempic, Zepbound, Mounjaro, Rybelsus, Saxenda, Victoza, or GLP-1, and inserts any match into the table above. We do not edit FDA’s text — every row links to the canonical FDA letter.
For the long-form narrative across FDA, Hims, Novo Nordisk, and Eli Lilly enforcement waves, see our compounding-cliff timeline. For provider-by-provider GLP-1 compounding status, see our compounding-status tracker.
Spotted a letter we missed? Email [email protected] with the FDA URL.