The FDA is warning patients and healthcare professionals about safety and quality concerns involving compounded GLP-1 drugs and unapproved weight-loss drugs as adverse event reports involving compounded semaglutide and tirzepatide surpass 1,700.
Here are four things to know:
- As of May 31, 2026, the FDA had received 990 reports of adverse events associated with compounded semaglutide and more than 730 associated with compounded tirzepatide. The agency said the events are likely underreported because federal law does not require certain state-licensed pharmacies to submit adverse event reports. This comes months after the FDA outlined five restrictions barring pharmacies from compounding GLP-1s once branded versions leave the shortage list.
- The FDA has received multiple reports of adverse events, some requiring hospitalization, that may be related to dosing errors involving compounded injectable semaglutide. The agency has also received reports potentially related to compounded semaglutide or tirzepatide prescribed at doses beyond those included in FDA-approved drug labels. In April, the agency proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list and cited a facility for sterility failures in compounded semaglutide and tirzepatide production.
- The agency said retatrutide and cagrilintide cannot be used in compounding under federal law and have not been found safe and effective for any condition. The FDA has warned companies over unapproved drugs containing semaglutide, tirzepatide, retatrutide, survodutide or mazdutide marketed directly to consumers as “for research purposes” or “not for human consumption.” This follows a March wave of 30 warning letters to telehealth companies over false or misleading marketing claims — part of what the agency said was more enforcement activity in six months than in the prior decade combined. Separately, a July JAMA Health Forum study found some compounders tweaking formulations to sidestep the FDA’s copying ban, with most secret-shopped clinics adding ingredients such as B vitamins to their compounded semaglutide and tirzepatide.
- The FDA also flagged concerns involving fraudulent compounded GLP-1 drugs, improper refrigeration during shipping and multidose vials. The scrutiny comes as brand manufacturers pull back from compounding partners. Eli Lilly, for example, tightened rules for its telehealth partners in 2025, requiring platforms such as Ro and LifeMD to stop selling compounded tirzepatide and semaglutide now that shortages have ended, a move that sidelined Hims & Hers.
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