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 |
|---|---|---|---|---|---|---|---|
| Empower Clinic Services, LLC dba Empower Pharmacy | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | … including TIRZEPATIDE/NIACINAMIDE (4 ML)(17/2 MG/ML), SEMAGLUTIDE/CYANOCOBALAMIN (1 ML)(5/0.5 MG/ML), and … which appear to be essentially copies of FDA-approved semaglutide and tirzepatide products. 3, 4 FDA is aware of high demand for compounded versions of FDA-approved semaglutide and tirzepatide products. The volume of products … | ||||
| Peak Performance Peptides | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | … Based on our review, “Bac water,” “GLP-3R” (retatrutide), “Semaglutide,” “SS-31,” “PT-141,” and “Tesamorelin” 1 are … of your website, “Bac water,” “GLP-3R” (retatrutide), “Semaglutide,” “SS-31,” “PT-141,” and “Tesamorelin” are drugs … models of cardiometabolic and metabolic research” Semaglutide On, e.g., the webpage … | ||||
| Royal Peptides LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | … in July 2026. Based on our review, “Tirzepatide,” “Semaglutide,” “Retatrutide,” “SS-31 (Elamipretide),” … Based on a review of your website, “Tirzepatide,” “Semaglutide,” “Retatrutide,” “SS-31 (Elamipretide),” … limited to, the following: Tirzepatide, Retatrutide, and Semaglutide On the webpage … | ||||
| NuScience Peptides LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | … benefit and weight loss** In hypercholesterolemia, semaglutide is believed to reduce the progression of … via the reduction of appetite and food cravings after semaglutide administration.” GLP-3 RT (Retatrutide) Research … | ||||
| Peptide Partners LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | … in July 2026. Based on our review,“GLP-1 S (Semaglutide),” “GLP-2 T (Tirzepatide),” “GLP-3 Reta … Violations Based on a review of your website, “GLP-1 S (Semaglutide),” “GLP-2 T (Tirzepatide),” “GLP-3 Reta … but may not be limited to, the following: GLP-1 S (Semaglutide) On the webpage … | ||||
| TXP Innovations LLC dba Tex Peptides | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | … website texpeptide.com in July 2026. Based on our review, “Semaglutide (GLP-1 SEM),” “Tirzepatide (GLP-2 TRZ),” … New Drug Violations Based on a review of your website,“Semaglutide (GLP-1 SEM),” “Tirzepatide (GLP-2 TRZ),” … but may not be limited to, the following: GLP-1 SEM (Semaglutide) On the webpage … | ||||
| NativeMed LLC dba NativeMed | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | … your website offers compounded drug products, including semaglutide and tirzepatide products. 1 As described below, … website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) … or operations. Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. … | ||||
| HydraMed IV LLC dba HydraMed | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | … your website offers compounded drug products, including semaglutide and tirzepatide products. 1 As described below, … website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) … or operations. Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. … | ||||
| Nexus Health Solutions LLC dba Harper Meds | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | … your website offers compounded drug products, including semaglutide and tirzepatide products. 1 As described below, … website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) … or operations. Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. … | ||||
| FitRX, LLC dba AM RX | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | … your website offers compounded drug products, including semaglutide and tirzepatide products. 1 As described below, … website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) … or operations. Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. … |