Warning Letters
Learn about the types of warning letters on FDA's website.
- Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.
- To obtain additional available information, contact FDA. Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5630 Fishers Lane, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at How to Make a FOIA Request.
- Frequently requested records may be accessed on the Reading Room page.
| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter | Excerpt |
|---|---|---|---|---|---|---|---|
| FitRX, LLC dba AM RX | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | … FitRX, LLC dba AM RX … June 8, 2026 WARNING LETTER Reference … | ||||
| FitRX, LLC dba FitRx | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | … FitRX, LLC dba FitRx … WARNING LETTER February 20, 2026 FitRx: This letter is to advise you that the United States … tirzepatide products displayed on your website identify “FitRx” on the pictured label, suggesting FitRx is the … | ||||
| FitRX, LLC dba Zealthy | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) | … FitRX, LLC dba Zealthy … WARNING LETTER September 9, 2025 … |