FDA adds a border screen and a fraudulent-label warning to its unapproved GLP-1 guidance

The FDA has updated its public page on unapproved GLP-1 drugs with two new warnings: a border screening program for imported GLP-1 drug ingredients, and an alert about fraudulent compounded semaglutide and tirzepatide sold with false information on the label ^[1][2].

What the border action does

The agency says it has established a "green list" import alert, numbered 66-80, to help stop GLP-1 active pharmaceutical ingredients (APIs) with potential quality concerns from entering the U.S. supply chain ^[1]. APIs are the raw drug substances a compounder starts with; they are also called bulk drug substances ^[1].

The alert does not apply to GLP-1 API from manufacturers that, based on an FDA inspection or other FDA evaluation, appear to comply with the agency's manufacturing standards ^[1]. The FDA states the action does not stop legal importation of GLP-1 APIs from compliant manufacturers and does not create new limits on the legal compounding of GLP-1 drugs ^[1]. The stated goal is to protect consumers from poor-quality compounded drugs made with foreign APIs that may be produced without controls to assure quality ^[1]. The FDA page does not give a start date for the import alert or say how many manufacturers are covered ^[1].

Labels that name pharmacies that did not make the drug

Separately, the FDA says it is aware of fraudulent compounded semaglutide and tirzepatide marketed in the U.S. with false information on the product label ^[1]. In some cases, the compounding pharmacies named on the labels do not exist ^[1][2]. In other cases, the label carries the name of a real licensed pharmacy that, based on information the FDA gathered, did not compound the product ^[1].

The agency cites one reported adverse event tied to a product labeled as compounded tirzepatide from a pharmacy that did not actually compound it. The report described redness, swelling at the injection site, pain, and a red lump at the injection site ^[1]. The FDA does not name the products or pharmacies involved, and does not say how widespread the fraudulent labeling is ^[1].

The agency also added a new item to its list of telehealth red flags for consumers: a pharmacy name on the label that a buyer thinks might be fraudulent ^[1]. Other red flags on that list include 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 from what a local pharmacy previously dispensed, no screening or prescription by a licensed doctor, and spelling errors or incorrect pharmacy addresses on the label ^[1].

The rest of the update

The same page carries the FDA's running adverse event tallies. As of May 31, 2026, the agency had received 990 reports of adverse events associated with compounded semaglutide and more than 730 associated with compounded tirzepatide ^[1]. The FDA notes that state-licensed pharmacies that are not outsourcing facilities are not required by federal law to report adverse events, so the real numbers are likely higher, and that many reported events look similar to those seen with the FDA-approved versions ^[1].

The page also repeats existing concerns: complaints that some compounded GLP-1 shipments arrived warm or with inadequate ice packs ^[1][2]; multi-dose vials, which the FDA generally says should be discarded 28 days after first use because of contamination risk ^[1]; dosing errors, some requiring hospitalization, from patients or clinicians measuring or calculating incorrect doses ^[1]; the use of semaglutide salt forms such as semaglutide sodium and semaglutide acetate, which are different active ingredients from the approved drug ^[1]; and retatrutide and cagrilintide, which the agency says cannot be used in compounding under federal law ^[1].

Why it matters for patients

The practical upshot is that the pharmacy name printed on a compounded GLP-1 vial is no longer a guarantee of where the medicine came from ^[1]. That undercuts one of the checks people have used to judge a telehealth supplier.

The import alert works upstream, at the point ingredients enter the country, so its effects on what arrives in a patient's mailbox may not be visible right away ^[1]. The FDA says compounded drugs are not reviewed for safety, effectiveness or quality before marketing, and that they should only be used when an FDA-approved drug cannot meet a patient's medical need ^[1].

The agency encourages patients, clinicians and compounders to report adverse events or quality problems through MedWatch ^[1].