FDA count reaches 990 adverse event reports for compounded semaglutide

The U.S. Food and Drug Administration has updated its running tally of safety reports tied to compounded GLP-1 drugs. As of May 31, 2026, the agency said it had received 990 reports of adverse events associated with compounded semaglutide and more than 730 reports associated with compounded tirzepatide ^[1].

The agency added an important caveat: federal law does not require state-licensed pharmacies that are not outsourcing facilities to submit adverse event reports to FDA, so "it is likely that adverse events from compounded versions of these drugs are underreported" ^[1]. FDA also noted that many of the reported events look similar to side effects already seen with the FDA-approved versions of these medicines, and that it is not always possible to tell whether a drug directly caused an event or whether other factors contributed ^[1].

What the reports involve

FDA describes several patterns behind the numbers. One is dosing errors. The agency said it received multiple reports of adverse events, some requiring hospitalization, that may be related to dosing errors with compounded injectable semaglutide products. Those errors came from patients measuring and self-administering incorrect doses, and in some cases from health care professionals miscalculating doses ^[1].

A second pattern involves doses that go beyond what appears on the FDA-approved labels. FDA said it has received reports that may be related to patients prescribed compounded semaglutide or tirzepatide at higher single doses, more frequent doses, or faster titration schedules than approved labeling describes. Some of those events were serious, and some patients sought medical attention for nausea, vomiting, diarrhea, abdominal pain and constipation ^[1].

FDA also flagged fraudulent products. The agency said it is aware of compounded semaglutide and tirzepatide sold in the U.S. with false label information. In some cases the compounding pharmacy named on the label does not exist; in others, the label names a real licensed pharmacy that did not make the product ^[1]. FDA said it knows of one reported adverse event tied to a product labeled as compounded tirzepatide from a pharmacy that did not actually compound it, with symptoms including redness, injection-site swelling, pain and a red lump ^[1].

Other agency concerns

Beyond the report counts, FDA listed several quality issues specific to compounded GLP-1s. Multi-dose vials are one. FDA generally recommends that vials holding multiple doses of sterile medication be discarded within 28 days after first use because contamination risk rises after that, and it says consumers should not keep using a vial past 28 days even if a compounder's instructions say otherwise, and should use a new sterile needle and syringe for each dose ^[1].

Shipping is another. Injectable GLP-1 drugs require refrigeration per their package inserts, and FDA said it has received complaints that some compounded GLP-1 drugs arrived warm or with inadequate ice packs ^[1].

FDA also said salt forms such as semaglutide sodium and semaglutide acetate are different active ingredients than those in approved drugs, and the agency is not aware of any lawful basis for using them in compounding ^[1]. Retatrutide and cagrilintide cannot be used in compounding under federal law, and FDA has issued warning letters to telehealth companies marketing unapproved drugs such as retatrutide, to active pharmaceutical ingredient distributors, and to outsourcing facilities repackaging retatrutide ^[1]. The agency has also set up a "green list" import alert (66-80) aimed at blocking GLP-1 active ingredients with potential quality concerns from entering the U.S. supply chain, while allowing imports from manufacturers that appear compliant ^[1].

Why it matters for patients

These counts are a floor, not a full picture. Because many compounding pharmacies are not required to report, the published totals almost certainly understate how often problems occur ^[1]. That makes it hard for anyone to compare the safety record of compounded products against the branded versions in a numerical way.

The pattern FDA describes also points to where risk concentrates: measuring and injecting a dose yourself from a vial, rather than using a pre-filled pen, and following titration schedules that differ from approved labeling ^[1]. FDA says compounded drugs are not reviewed by the agency for safety, effectiveness or quality before marketing, and should only be used when a patient's medical need cannot be met by an FDA-approved drug ^[1].

The agency also lists telehealth warning signs, including claims that a compounded drug is the same as an FDA-approved drug, prices that seem too good to be true, medicine that looks different than expected or arrives in damaged packaging, and no licensed doctor screening or available for follow-up questions ^[1].

What happens next

FDA says it is working with state regulatory partners and will keep communicating with compounders about these concerns ^[1]. The agency updates the report counts periodically; the current figures are dated May 31, 2026 ^[1]. FDA encourages health care professionals, patients and compounders to report adverse events or quality problems through MedWatch ^[1]. When the next update will publish is not stated in the source.