Compounded and Unapproved GLP-1 Products: Regulator Warnings

Compounded GLP-1 products

Compounded drugs are made by a pharmacy or other compounder, usually for a specific patient. FDA says compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug, and that patients should get a prescription from their doctor and fill it at a state-licensed pharmacy. [1] FDA lists these concerns about compounded semaglutide and tirzepatide:

• Dosing errors. FDA received multiple reports of adverse events, some requiring hospitalization, that may be related to dosing errors with compounded injectable semaglutide, including patients measuring incorrect doses and clinicians miscalculating them. [1]
• Doses beyond the label. FDA also received reports that may be related to prescribed doses beyond those in the approved drug labels, with symptoms such as nausea, vomiting, diarrhea, abdominal pain and constipation. [1]
• A different active ingredient. Some semaglutide products sold by compounders are salt forms (semaglutide sodium, semaglutide acetate). FDA says these are different active ingredients than those in the approved drugs and it knows of no lawful basis for their use in compounding. [1]
• Multiple-dose vials. FDA notes an increased risk of contamination after 28 days of use of multiple-dose vials. [1]
• Shipping and storage. FDA received complaints that some compounded products arrived warm or with inadequate ice packs. [1]
• Underreporting. Federal law does not require state-licensed pharmacies that are not outsourcing facilities to submit adverse events to FDA, so events are likely underreported. As of May 31, 2026, FDA had received 990 reports for compounded semaglutide and more than 730 for compounded tirzepatide. FDA adds that it is not always possible to tell whether an event resulted from the drug. [1]
• Fraudulent labels. Some products carry false labels naming pharmacies that do not exist or that did not make the product. [1]

For the general rules on compounding and why it is not approval, see compounded medicines.

Counterfeit and illegally sold products

FDA says it is aware of counterfeit Ozempic marketed in the United States, which could contain the wrong ingredients or too little, too much or no active ingredient. [1] In the United Kingdom, the NHS page on semaglutide (read 2026-10-22) advises that a private prescription for semaglutide injections (Wegovy) be bought from a registered pharmacy because some websites sell fake weight loss medicines. [2]

One published market study (Journal of Medical Internet Research, 2024) examined semaglutide sold online without a prescription. Its test purchases from 6 illegal online pharmacies delivered three injection vials (none of three prefilled pens arrived). All vials were considered probable substandard and falsified; semaglutide content exceeded labeled amounts by 28.56% to 38.69%, endotoxin was detected in all samples, and measured purity (7.7% to 14.37%) was far below the 99% claimed. [3] This is a small test-purchase study, not a measure of every product.

"Research use" and other unapproved peptides

FDA has warned companies that illegally sold unapproved drugs containing semaglutide, tirzepatide, retatrutide, survodutide or mazdutide falsely labeled "for research purposes" or "not for human consumption" and sold directly to consumers with dosing instructions. FDA urges consumers not to purchase these products, which are of unknown quality. [1] FDA also says retatrutide and cagrilintide cannot be used in compounding under federal law, are not components of FDA-approved drugs, and have not been found safe and effective for any condition. [1] Label: unapproved; evidence of benefit and safety not established by a regulator.

Red flags FDA lists for telehealth sellers

Claims that a compounded drug is the same as an approved drug, prices that seem too good to be true, medicine that looks different from before or arrives in damaged or incomplete packaging, no screening and prescription by a licensed doctor, no licensed doctor available afterwards, spelling errors on the label, and a pharmacy name that may be fraudulent. [1]

Reporting problems

FDA encourages health care professionals, patients and compounders to report adverse events or quality problems to its MedWatch program, online or by form. [1] If you have severe symptoms, seek urgent care (US emergency number 911). See GLP-1 medicines, unsafe products and warnings, side effects and reporting and peptide safety.