Hims & Hers discontinued its compounded oral semaglutide pill following FDA scrutiny and a patent infringement lawsuit from Novo Nordisk in February 20261
The FDA announced in early February 2026 that it would take 'decisive steps' to restrict compounded GLP-1s from being mass marketed as similar to FDA-approved drugs, specifically naming Hims1
Novo Nordisk filed a patent infringement lawsuit against Hims on Monday, February 10, 2026, claiming the company was mass marketing unapproved versions of Wegovy and Ozempic2
Following the regulatory pressure, Novo Nordisk and Hims & Hers reached an agreement allowing Hims to offer multiple FDA-approved Novo Nordisk GLP-1 medications including various doses of Ozempic injections and Wegovy tablets and injections2
Hims' stock fell 35% between Thursday and the following week in mid-February 2026 due to the regulatory crisis1
The FDA issued warning letters in fall 2025 targeting misleading direct-to-consumer advertising by compounding companies claiming non-FDA-approved products were equivalent to FDA-approved drugs2
Sources:
1. https://www.statnews.com/2026/02/11/hims-federal-scrutiny-impact-on-telehealth-compounding-pharmacies/
2. https://www.pharmexec.com/view/novo-nordisk-signs-deal-hims-hers