# FDA Warning Letters on Compounded Tirzepatide in 2025 and 2026

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FDA · 2026-02-24


    Beginning in mid-2025 and continuing into 2026, the FDA issued a series of warning letters to compounding pharmacies and outsourcing facilities producing compounded tirzepatide. The letters cite violations including unapproved new drug manufacturing, lack of valid prescriptions, API sourcing from unregistered facilities, and misbranding. The letters typically demand corrective action within 15 working days, and failure to respond adequately can escalate to injunction, seizure, or criminal referral. By early 2026 at least 28 such letters had been made public, with additional enforcement activity ongoing.


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