FDA restates that retatrutide and cagrilintide cannot be compounded

The agency’s standing alert on unapproved GLP-1 products now names both molecules directly, and describes warnings issued to the distributors selling them.

The FDA’s alert on unapproved GLP-1 products was refreshed in June, and it now addresses two lines in this catalogue by name. Retatrutide and cagrilintide cannot lawfully be used in compounding: neither is a component of an FDA-approved drug, and neither has been found safe and effective for any condition.

What the agency says it has done

The alert lists warnings issued to telehealth companies marketing retatrutide, to active pharmaceutical ingredient distributors selling it to compounders, and to outsourcing facilities repackaging it. It also describes a border measure, import alert 66-80, operated as a green list and intended to keep GLP-1 API of unknown quality out of the US supply chain while leaving compliant manufacturers alone.

Separately, the agency notes that semaglutide salt forms — including the sodium and acetate salts — are different active ingredients from the one in the approved products, and that it is aware of no lawful basis for compounding with them. As of 31 May 2026 it had received 990 adverse event reports associated with compounded semaglutide and more than 730 associated with compounded tirzepatide.

Why we are posting it

None of this changes what we do, because none of what we do is compounding. MET-01 through MET-06 are supplied as laboratory reagents to verified research organisations, labelled Research Use Only, and are not for human consumption. The part worth reading is the part about API: the agency is describing a trade in bulk peptide that moves without a reliable account of where it was made or how it was held. That is the trade this company was started to argue with.

Source: FDA, alert on unapproved GLP-1 drugs used for weight loss, content current as of 15 June 2026.

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