Which GLP-1 providers have FDA warning letters? 13 companies, 6 of them programs we rank

Tracker and Agency Timeline

Companies with FDA Warning Letters

Every row below links to the FDA warning letter itself, by its MARCS-CMS reference number. This list is not exhaustive, the FDA has issued far more, and we only publish letters we have located and linked. Rows marked we rank this provider are companies that appear in our own rankings, including ones we earn affiliate commission from.

Want records without a sourced warning letter in this tracker? See the public-record list below, or search any tracked company in our Warning & Transparency Checker. Absence from the tracker does not establish safety or compliance. For the short version, see which records warrant extra review and how to evaluate an online pharmacy.

No Sourced FDA Warning Letter in This Tracker

These providers in our partner comparison do not have a sourced FDA warning letter in our current dataset. That is a limited public-record observation, not confirmation of safety, pharmacy licensing, current compliance, or operational legitimacy. Each name links to its full review; see the underlying fields in our Warning & Transparency Checker.

Semaglutide Recalls in the Compounding Supply Chain

A warning letter is about what a company said. A recall is about what shipped. These are separate FDA channels with different firms in them, and none of the 4 firms in the compounding rows below is a program we rank, so no provider on this site is named in these records. That cuts both ways: the compounder or the active-ingredient maker behind a telehealth brand is usually not disclosed to the patient, so a shopper generally cannot tell from the website whether their vial came through one of these firms. What the 16 compounding-chain records do show is where the failures cluster, and as of the records reported 2026-08-19 that is no longer mainly sterility. 11 of the 16 were recalled for particulate matter, something physically in the vial, against 3 for sterility assurance and the rest for process and endotoxin validation at the raw-ingredient step. All are Class II. The branded row is included for contrast, not for balance.

Every row is transcribed from the openFDA drug enforcement API most recently 2026-08-26, each row either by its FDA recall number or, for the Apollo Care cluster, by a report-date range query that returned the eleven records together. The newest record here was reported 2026-08-19. openFDA's enforcement index publishes on its own lag, so a recall more recent than that may not be indexed yet, and its absence here is not evidence it did not happen. Every row now carries the quantity, initiation date and distribution pattern openFDA reports for it; where a field reads N/A, that is what the record itself contains. Status is FDA's own: Ongoing means the recall is not yet recorded as completed, so product may still be in the channel. Class II means FDA judged that exposure may cause temporary or medically reversible harm, with a remote probability of serious harm. Compounded semaglutide is not an FDA-approved product in any case, whatever its recall history.

Shopping compounded programs on price? Our cheapest GLP-1 programs breakdown and brand vs compounded comparison both cover what you are trading away for the lower price. Ask any provider which 503A or 503B pharmacy fills your prescription, and check that pharmacy against the FDA drug recall archive. This is public-record reporting, not medical advice; talk to your prescriber before changing or stopping any medication.

How to read a warning letter in this tracker

Each letter must be read for its own allegations. The sourced letters here fall into distinct categories, and no letter contains every one:

• Post-shortage compounding conditions. Ending enforcement discretion for shortage-based copies did not create a universal ban; each preparation must satisfy the applicable 503A or 503B and state-law conditions.
• Semaglutide salt forms. FDA says it is not aware of a lawful basis for using semaglutide sodium or acetate in compounding under the cited statutory conditions.
• Misleading brand comparisons. Several letters address claims that compounded products were approved, generic, identical or clinically equivalent to Wegovy, Ozempic, Zepbound or Mounjaro.
• Labeling, manufacturing or record issues. Letter-specific; never infer them from a marketing-only citation.

Three things the record does not say on its own. A letter can name a marketer or telehealth provider even when another entity compounded the medication. Semaglutide and tirzepatide claims both appear, so read the product and conduct cited rather than generalising across a company or a drug class. And a warning letter is not a final adjudication; a later close-out record can change the current context materially. FDA separately announced 30 telehealth marketing letters on March 3, 2026, which is broader than the individually linked rows here; this tracker is curated and not exhaustive, and publishes no cumulative national total for that reason.

If you are on a compounded GLP-1 today, four questions for your provider

• Which pharmacy fills my prescription? The answer should be a specific 503A or 503B pharmacy name, not "our network" or "our partner".
• Is that pharmacy on the FDA warning-letter list? Check the FDA database or the safety checker.
• What patient-specific rationale and legal pathway does the prescriber document? It should address the actual formulation and the applicable 503A or 503B conditions, not a generic claim that all compounded products are legal.
• What ingredient and concentration are on the label? Confirm the formulation, mg/mL concentration, vial size and syringe units with the dispensing pharmacist; never infer them from a brand dose.

If a provider cannot answer these, pause and ask the prescriber or pharmacist for the records before paying or dosing. The safety checker summarises selected public records; it does not maintain a "verified compliant" list or certify any provider as safe.