Which GLP-1 providers have FDA warning letters? 9 companies, 5 of them programs we rank
This tracker contains 9 sourced FDA warning-letter records involving compounded GLP-1 marketing or sales, and 5 are programs we rank ourselves: Eden Health GLP-1, Maximus, SkinnyRx, MEDVi, Strut Health. Every row links to the letter on fda.gov by its reference number. The FDA has issued far more than are listed here; we publish only the ones we have located and verified.
Across the sourced letters, FDA cited issues including:
- Marketing that implied compounded products were the same as, or FDA-reviewed like, approved brands
- Labels that obscured which entity compounded the prescription
- Unlawful online sales of unapproved or misbranded products in some letters
Not every letter makes every allegation, and a marketing or labeling citation is not by itself a finding that medication was unsafe.
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.
| Company | Warning Date | Reason | Source |
|---|---|---|---|
| Eden Health GLP-1we rank this provider | 2026-06-08 | Part of the FDA's June 8, 2026 action against telehealth companies marketing compounded GLP-1 drugs: false or misleading claims rendering the products misbranded. | FDA #728279 |
| Maximuswe rank this provider | 2026-06-08 | FDA review of the Maximus website in May 2026 found it offering compounded semaglutide and tirzepatide products with claims the agency deemed false or misleading, rendering them misbranded. | FDA #730095 |
| SkinnyRxwe rank this provider | 2026-02-20 | Misbranding under FDCA 502(a) and 502(bb): compounded semaglutide and tirzepatide shown on skinnyrx.com carried labels identifying SkinnyRx, implying SkinnyRx compounded the drugs when it does not, alongside false or misleading website claims. | FDA #717989 |
| MEDViwe rank this provider | 2026-02-20 | Misbranding under FDCA 502(a) and 502(bb): MEDVi-branded product labels implied MEDVi compounded the drugs when it did not, and website claims comparing compounded semaglutide and tirzepatide with FDA-approved brands implied equivalence or FDA evaluation the compounded products do not have. | FDA #721455 |
| FITISH | 2026-06-08 | False or misleading claims rendering compounded GLP-1 products misbranded, in the FDA's June 8, 2026 telehealth action. | FDA #728280 |
| Lovely Meds | 2025-09-09 | FDA review of the website in August 2025 found compounded semaglutide and tirzepatide offered with claims including 'Same active ingredient as Wegovy and Ozempic' and 'Same active ingredient as Zepbound & Mounjaro', which imply the compounded products are the same as the FDA-approved drugs when they are not. | FDA #716829 |
| GLP-1 Solution | 2025-09-09 | Unlawful sale of unapproved and misbranded drugs to United States consumers over the internet. | FDA #715883 |
| Vitals RX | 2025-09-09 | Unlawful sale of unapproved and misbranded drugs to United States consumers over the internet. | FDA #715868 |
| Strut Healthwe rank this provider | 2026-02-20 | Misbranding: compounded semaglutide/tirzepatide product labels displayed 'Strut' branding implying Strut itself was the compounder (it is not), and website marketing claims implied the compounded products were FDA-evaluated for safety and effectiveness. | FDA #721448 |
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 records 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 3 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 5 compounding-chain records do show is where the failures cluster, sterility assurance at the compounding step and process and endotoxin validation at the raw-ingredient step, both Class II. The branded row is included for contrast, not for balance.
Every row is transcribed from the openFDA drug enforcement API by its FDA recall number, fetched 2026-08-18. openFDA's enforcement index was last updated 2026-08-12, so anything recalled after that date is not in this list yet and its absence here is not evidence it did not happen. 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.
| Recalling Firm | Product | Reason | Initiated | Record |
|---|---|---|---|---|
PAYLESS COMPOUNDERS, LLC Beaverton, OR · compounding pharmacy | Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR 91 vials recalled | Lack of Assurance of Sterility Class II · distributed OR | 2026-03-06 reported 2026-04-22 | D-0471-2026 |
New Life Pharma LLC Northvale, NJ · repackager / relabeler | Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, NDC 84223-001-07 820 vials recalled | Lack of Assurance of Sterility Class II · distributed OH | 2026-02-26 reported 2026-03-11 | D-0392-2026 |
New Life Pharma LLC Northvale, NJ · repackager / relabeler | Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, NDC 84223-001-06 2 vials recalled | Lack of Assurance of Sterility Class II · distributed OH | 2026-02-26 reported 2026-03-11 | D-0393-2026 |
Harbin Jixianglong Biotech Co., Ltd. Harbin, China · active-ingredient maker | Semaglutide, For Rx compounding use only, packaged in 1g, 5g, 10g, 25g and 50g (NDC 84385-106-01 through 84385-106-04) | CGMP Deviations. This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution Class II · distributed Nationwide within the United States | 2026-02-13 reported 2026-03-11 | D-0379-2026 |
Harbin Jixianglong Biotech Co., Ltd. Harbin, China · active-ingredient maker | Semaglutide, For Rx compounding use only, packaged in 1g, 5g, 10g, 25g, 50g and 100g (NDC 84385-106-01 through 84385-106-05) | CGMP Deviations. This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution Class II · distributed Nationwide within the United States | 2026-02-13 reported 2026-03-11 | D-0380-2026 |
Novo Nordisk Inc. Plainsboro, NJ · FDA-approved brand | Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, NDC 0169-4501-14 | Presence of Particulate Matter: Hair was found in a prefilled syringe Class II · distributed Nationwide within the United States. | 2025-12-19 reported 2026-01-07 | D-0245-2026 |
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.
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