FDA GLP-1 Compounding Enforcement Tracker
Every FDA action on compounded GLP-1 drugs since the shortages ended: what each warning letter cited, and what it means if you run a weight-management program. Each entry links to the FDA document it comes from.
- warning letters to telehealth companies over compounded-drug marketing in 2025
- 58
- FDA Office of Compliance, 2025 annual report
- more telehealth letters announced on a single day, March 3, 2026
- 30
- FDA press announcement
- from FDA reading a brand’s website to the letter, in the cases below
- 1–3 months
- Dates recorded in each letter
What the record says
Read the letters together instead of one at a time and a few things stand out. This is our reading of them, as a company that builds and reviews GLP-1 programs for clinics.
- 1.
The letters moved to the storefront.
Since September 2025, most GLP-1 warning letters have gone to the businesses selling the product rather than the pharmacies making it. FDA counted 58 to telehealth companies in 2025 and announced 30 more on a single day in March 2026. The brand letters below cite what was on a website, not anything an inspector found.
- 2.
Five phrases do most of the damage.
“Same active ingredient as” (or “same results as”). “FDA-approved.” “FDA-licensed pharmacy.” “Clinically proven.” And a product label with your brand on it. Every telehealth letter in this tracker quotes at least one of them. None takes bad intent to write, because each one sits right next to something true. The checker further down looks for all of them.
- 3.
The gap between review and letter is one to three months.
Measured’s site was reviewed in December and the letter came in February. Medica Weight Loss, FITISH and Altru were reviewed in March and received letters in June. Peptide Partners: July, then August. Nobody is told a review is happening, so the practical assumption is that whatever your site says today is what a letter next quarter would quote.
- 4.
A disclaimer does not outweigh the page.
Sellers labeled products “for research use only” and FDA treated them as drugs for people anyway, because the rest of the site said otherwise. The same logic runs the other way: a careful FAQ does not cancel a hero banner that says “same as Ozempic.”
- 5.
Supply risk and marketing risk are separate problems.
The pharmacy side still runs on inspections and moves slowly: about ten months from inspection to letter in the September 2026 case. Meanwhile the April 2026 proposal to keep semaglutide, tirzepatide and liraglutide off the 503B bulks list is still open. A compliant pharmacy partner does not cover your marketing, and clean marketing does not secure your supply.
The timeline
12 actions and 12 individual letters, newest first. Last checked October 13, 2026.
2026
- Warning letters
Pharmacy letter after an inspection
FDA issued a warning letter after inspecting a Houston compounding facility in November 2025. It cited sterile drugs prepared, packed or held under insanitary conditions, adulterated under section 501(a)(2)(A), and products that failed the conditions of section 503A, including compounding large quantities of a tirzepatide preparation over three months.
Recipient What FDA cited Empower Clinic Services, LLC (dba Empower Pharmacy) Compounding pharmacy · inspected November 2025- Insanitary conditions, section 501(a)(2)(A)
- Failure to meet section 503A conditions, including volume tirzepatide compounding
What it means: The pharmacy side of enforcement still runs on inspections, and it takes longer: about ten months from inspection to letter here.
- Warning letters
“Research use only” labels did not help
FDA reviewed the seller's website in July 2026 and called a range of its products unapproved new drugs, including retatrutide, semaglutide and tirzepatide. The labels said “for research use only” and “not for human or veterinary use”; FDA said the website showed the products were intended for human use anyway. FDA posted letters to other peptide sellers with the same date.
Recipient What FDA cited Peptide Partners LLC Online peptide seller · site reviewed July 2026- Unapproved new drugs, including retatrutide, semaglutide and tirzepatide
- “Research use only” labeling contradicted by the website
What it means: A disclaimer does not outweigh the rest of the page. FDA reads the whole site.
- Warning letters
Same-day letters to six GLP-1 sellers
FDA issued warning letters the same day to businesses selling compounded GLP-1 products to consumers. None is a pharmacy. Each letter records that the violations were found by reviewing the company's own website.
Recipient What FDA cited Maximus Health, Inc. (dba Maximus) Telehealth company · site reviewed May 2026- Sourcing claims citing “FDA approved pharmacies”
Medica Weight Loss Weight-management clinic · site reviewed March 2026- Labels reading “medica weight loss,” suggesting it is the compounder
- Language that clinical studies and FDA approval support semaglutide's safety
- Describing tirzepatide as FDA-approved
Ready Med Telehealth company · site reviewed May 2026- An “FDA licensed compounding facility”
- Same active ingredient as Mounjaro and Zepbound, and as Ozempic and Rybelsus
- Product labels carrying its own name
FITISH Telehealth company · site reviewed March 2026- Product labels carrying its own name, suggesting it is the compounder
Trinity HealthCare Supply, LLC (dba altRx) Telehealth company- Semaglutide and tirzepatide labels bearing the altRx name
- “Clinically proven” claims
Altru Telehealth, LLC Telehealth company · site reviewed March 2026- Claims that compounded products offer the same results at a lower price
What it means: Four of the six were cited for a product label carrying their own name.
- Proposal
Proposal to keep semaglutide, tirzepatide and liraglutide off the 503B bulks list
FDA proposed excluding the three from the 503B bulks list, on a finding that there is no clinical need for outsourcing facilities to compound them from bulk substances. Comments closed June 29, 2026. It is a proposal, not a final decision.
What it means: Supply from outsourcing facilities is the open question to watch; any program that depends on it needs a fallback plan.
- Report
FDA's 2025 compliance report puts a number on it
FDA's Office of Compliance annual report counted 58 warning letters in 2025 to telehealth companies selling misbranded compounded products, out of 314 warning letters the report covers. Misleading advertising of compounded drugs made up 19 percent of all letters issued.
What it means: Misleading advertising of compounded drugs was behind roughly one in five of the warning letters in that report for 2025.
- Warning letters
“Research peptide” seller cited for GLP-1 products
FDA reviewed the seller's website from January to March 2026 and found retatrutide, tirzepatide and bacteriostatic water offered for sale. It treated marketing about appetite suppression and weight reduction as evidence the products were intended as drugs, making them unapproved new drugs under sections 301(d) and 505(a).
Recipient What FDA cited Gram Peptides Online peptide seller · site reviewed January to March 2026- Unapproved new drugs, including retatrutide and tirzepatide
- Weight-reduction and appetite claims as evidence of intended use
What it means: Selling outside the prescription channel does not move a product outside FDA's reach; the marketing decides what the product is.
- Announcement
30 warning letters to telehealth companies
FDA announced 30 warning letters to telehealth companies over false or misleading claims about compounded GLP-1 products on their websites. The main violations: implying sameness with FDA-approved products, and selling compounded drugs under the telehealth company's own name or trademark without making clear that a separate compounder supplies them. FDA said it had sent more advertising warning letters to drug and telehealth firms in the prior six months than in the preceding decade.
What it means: Two claim types account for most of the letters, and both are fixable with a text editor.
- Warning letters
Letter to a telehealth brand reviewed in December
FDA reviewed the company's website in December 2025 and found it offered compounded semaglutide and tirzepatide. The letter followed two months later.
Recipient What FDA cited Better Health Labs, Inc. (dba Measured) Telehealth company · site reviewed December 2025- Product labels naming the brand, suggesting it is the compounder when it is not
- Claims that its compounded GLP-1s use the same active ingredients as Wegovy, Ozempic, Zepbound and Mounjaro
What it means: The review-to-letter gap here was about two months, and the brand never had an inspector on site.
- Announcement
FDA says it intends to act against non-approved GLP-1 drugs
FDA announced it intends to restrict GLP-1 active ingredients used in non-FDA-approved compounded drugs marketed as alternatives to approved products. It stated that promotional materials may not claim a compounded product is a generic version of, the same as, or clinically proven to produce the same results as an FDA-approved drug, and warned that unaddressed violations could lead to seizure or injunction without further notice.
What it means: The marketing rules were now spelled out in a press release, so ignorance stopped being a plausible explanation.
2025
- Warning letters
Deceptive drug advertising crackdown, with the first telehealth letters
HHS and FDA announced a crackdown on misleading drug advertising: thousands of letters asking companies to remove misleading ads and about 100 cease-and-desist letters. The same day, FDA issued warning letters to telehealth companies selling compounded semaglutide and tirzepatide, citing website claims as false or misleading under sections 502(a) and 502(bb) of the FD&C Act.
Recipient What FDA cited Hims & Hers Health, Inc. (dba Hers) Telehealth company- “Same active ingredient as Ozempic and Wegovy”
Healthon Inc. (dba Healthon) Telehealth company- “Same active ingredient as Wegovy and Ozempic”
- “Same active ingredient as Mounjaro pens and Zepbound”
What it means: This is when telehealth storefronts, not just drug makers and pharmacies, became a named enforcement target.
- Policy
Semaglutide shortage declared resolved
FDA found that semaglutide injection supply meets or exceeds current and projected demand. It gave 503A pharmacies and physicians until April 22, 2025 and 503B outsourcing facilities until May 22, 2025 before it would act on shortage-dependent compounding.
What it means: Both major GLP-1 molecules were off the shortage list by spring 2025, and every enforcement action below happened after that.
2024
- Policy
Tirzepatide shortage declared resolved
FDA issued a declaratory order finding the tirzepatide injection shortage resolved. It replaced FDA's October 2, 2024 decision, which a court had sent back for reevaluation. FDA said it did not intend to act against 503A compounders through February 18, 2025, or against 503B outsourcing facilities through March 19, 2025.
What it means: The legal footing for copying a commercially available tirzepatide product went away once those dates passed.
Check your own copy
The checker looks for the phrases FDA has quoted back to sellers in the letters above. Each match tells you which letter cited it and what to say instead. It takes about ten seconds per page.
Runs in your browser. Nothing you paste is sent anywhere or stored.
If we were running your program, this week we would
- 1.Run every page that mentions GLP-1 through the checker above, including ads, email sequences and affiliate pages. Those last two are where old copy survives.
- 2.Look at every product photo. If your brand is on the vial, box or label and you are not the compounder, replace the image.
- 3.Replace “FDA-approved pharmacy” with what is true and provable, such as a state-licensed 503A pharmacy or an FDA-registered 503B outsourcing facility.
- 4.Describe your program, not the drug: the clinician evaluation, the follow-up, what the membership includes. Drop comparisons to brand-name products.
- 5.Put a date on the calendar every quarter to reread all of it, and check this page when you do.
Using this tracker
You are welcome to cite or link to it. The data is free to download as a CSV file, one row per letter, with the FDA link for each. We add a letter once we have confirmed what it cited from FDA’s own text, so the tracker lists fewer letters than FDA has issued; it is a record of what was cited, not a complete index. For that, search FDA’s warning letter database.
MDLaunchr, “FDA GLP-1 Compounding Enforcement Tracker,” updated October 13, 2026, https://www.whitelabelclinic.com/compliance/fda-glp-1-enforcement-tracker
Related reading
- FDA GLP-1 Compounding Warning Letters: What FDA Cited in 2026The long read on the June letters and what they mean for a branded clinic.
- What FDA Inspects at a Compounding Pharmacy, and What to AskThe pharmacy side of enforcement, and the questions to put to your partner.
- Telehealth Compounding Pharmacy: How to Choose and Verify a PartnerHow to check licensing and registration before you sign.
- 503A vs. 503B compoundingWhy the bulks-list proposal matters for one and not the other.
- How to Start a GLP-1 Business: A Pre-Launch ChecklistWhere marketing review fits in the launch sequence.
- GLP-1 Payment Processing Compliance 2026Processors read the same website FDA does, often first.
Educational material, not legal or medical advice. Summaries describe what each FDA document states; a warning letter is FDA’s position at the time it was issued, and recipients may respond or correct the issues cited. Confirm current requirements with counsel before relying on any of it.