What FDA’s record states
| Field | What FDA’s record states | Source |
|---|---|---|
| Recipient | Thrive Health and Wellness, LLC dba Thrive Health Solutions | FDA letter ↗ |
| Location | Englewood, CO | FDA letter ↗ |
| Letter date | Feb 9, 2026 | FDA letter ↗ |
| Posted by FDA | Apr 21, 2026 | FDA index ↗ |
| Issuing office | Center for Drug Evaluation and Research (CDER) | FDA letter ↗ |
| Subject | Compounding Pharmacy/Adulterated Drug Products | FDA letter ↗ |
| MARCS-CMS number | 714891 | FDA letter ↗ |
| GLP-1 drugs named | Tirzepatide | FDA letter ↗ |
| Response letter | Not published by FDA | FDA letter ↗ |
| Closeout letter | Published 08/06/2026 | FDA letter ↗ |
“Unapproved New Drug Products You do not have any FDA-approved applications on file for the drug products that you repackage, such as NAD+ 50 mg/mL and MEGALean (Tirzepatide/Cyanocobalamin) Injections 10mg/20mg/mL. These products are unapproved new drugs under sections 505(a) and 301(d) of the FDCA [21 U.S.C. § 331(d)].”FDA warning letter to Thrive Health and Wellness, LLC dba Thrive Health Solutions, Feb 9, 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.
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