Compounded and Unapproved GLP-1 Products: Regulator Warnings

The short version

GLP-1 medicines such as semaglutide and tirzepatide are approved prescription drugs. Other versions exist: compounded, counterfeit and "for research" products. The FDA says unapproved versions do not go through its review for safety, effectiveness and quality before marketing. [1] This page reports only what the FDA's page (current as of 10/01/2026) says. It is not legal advice, and it is not medical advice; talk with your prescriber. Labels: approved medicine applies only to the approved products; the others are unapproved.

Compounded GLP-1 products

Compounded drugs are made by a pharmacy or facility for a specific patient. The FDA says they should only be used when a patient's needs cannot be met by an approved drug, and that people should get a prescription from their doctor and fill it at a state-licensed pharmacy. [1] The FDA lists these concerns:

• Dosing errors. Reports of adverse events, some requiring hospitalization, that may be related to dosing errors with compounded injectable semaglutide. [1]
• Different active ingredient. Some products use salt forms (semaglutide sodium, semaglutide acetate), which are different ingredients from those in approved drugs; the FDA knows of no lawful basis for their use in compounding. [1]
• Storage. Complaints that some products arrived warm or with inadequate ice packs. [1]
• Contamination risk in multiple-dose vials. The FDA notes an increased risk of contamination after 28 days of use and gives patients directions on this; ask your pharmacist or prescriber. [1]
• Underreporting. Federal law does not require non-outsourcing state-licensed pharmacies to submit adverse events to the FDA, so reports are likely undercounted. As of May 31, 2026, the FDA had received 990 reports for compounded semaglutide and more than 730 for compounded tirzepatide, many resembling approved-drug effects. [1]
• Fraudulent labels. Some products carry false labels naming pharmacies that do not exist. [1]

Counterfeit products

The FDA says counterfeit Ozempic is marketed in the U.S. and may contain the wrong ingredients or too little, too much or no active ingredient. [1] The NHS also warns of websites selling fake weight-loss medicines. [2]

"Research use" and other unapproved peptides

The FDA has warned companies selling semaglutide, tirzepatide, retatrutide, survodutide or mazdutide falsely labeled "for research purposes" or "not for human consumption" that were sold with dosing instructions to consumers; it urges people not to purchase them because of unknown quality. [1] Retatrutide and cagrilintide cannot be used in compounding under federal law, are not components of approved drugs, and have not been found safe and effective for any condition. [1] Label: unapproved; evidence of benefit and safety not established.

Red flags the FDA lists for telehealth sellers

Claims that a compounded drug is the same as an approved drug, deep discounts, no screening or prescription by a licensed doctor, medicine that looks different from before, damaged or incomplete packaging, spelling errors on labels, and no licensed doctor available afterwards. [1]

What to do

Check with your prescriber and a licensed pharmacist. Adverse events and quality problems can be reported to the FDA's MedWatch program. [1] Outside the U.S., regulators differ; we did not verify other countries' rules. If you have severe symptoms, seek urgent care (U.S. 911). See GLP-1 medicines, unsafe products and warnings, side effects and reporting and peptide safety.