Compounder recalls copycat tirzepatide in FDA Class II action
The recall lands as roughly 20% of Americans on GLP-1s use compounded versions despite ended shortages and lawsuits from Lilly and Novo.
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By Maren Holt · Senior Reporter, GLP-1
Oct 22 11:50 ETSource: BioPharma Dive
The wire
- 01A compounder recalled copycat Zepbound (tirzepatide); FDA classified it Class II, meaning temporary or medically reversible harm, with serious consequences remote.
- 02Telehealth firms kept selling compounded GLP-1s via personalized regimens after shortages ended, and a Gallup survey found about 20% of US GLP-1 users take compounded forms.
- 03Lilly and Novo are escalating litigation, now including copies of experimental retatrutide, while HHS reportedly advances plans letting specialty pharmacies compound six peptides backed by an FDA advisory panel.
From the source
Read at biopharmadive.comGLP-1 compounder issues recall for copycat Zepbound
The notice adds to growing concerns about the safety of knockoff weight loss drugs, which have remained popular despite FDA warnings and legal pressure from Eli Lilly and Novo.
