Hims & Hers halts plan to distribute a compounded semaglutide pill following Novo Nordisk’s warning and subsequent FDA action on non-approved GLP-1 drugs
Written By: Pharmacally Medical News Desk
A rapid sequence of regulatory and industry responses has reshaped the debate around compounded GLP-1 drugs in the US, ending in Hims & Hers halting its plans to distribute a compounded semaglutide pill.
Hims & Hers has halted its decision to distribute a compounded semaglutide pill, following heightened regulatory scrutiny and public warnings from both the US Food and Drug Administration and Novo Nordisk.
The company confirmed the move in a statement posted on its official X communications account (@HimsHersComms), saying it would pause the rollout of the compounded semaglutide product amid ongoing regulatory developments. Hims & Hers has not issued a separate press release on its website regarding the decision.
The update follows a public warning from Novo Nordisk, which accused Hims & Hers of illegal mass compounding and raised concerns about patient safety and the integrity of the FDA’s drug approval framework.
In the days that followed, the U.S. Food and Drug Administration announced an action plan on 06 February 2026 to restrict non-FDA-approved compounded GLP-1 drugs and step up enforcement against misleading marketing practices.
The sequence began a day earlier, on 05 February 2026, when Hims & Hers announced plans to offer a compounded oral semaglutide pill through its platform. In its initial press release, the company positioned the product as a lower-cost option intended to expand access to GLP-1 therapy, emphasizing affordability, convenience, and continuity of care amid high demand for approved GLP-1 medicines. Hims & Hers said the compounded pill would be provided through partner pharmacies and framed it as a patient-focused solution, while noting that the product was not FDA-approved.
However, those positioning claims quickly drew scrutiny, as regulators and originator companies argued that promoting a compounded semaglutide pill as an alternative to FDA-approved therapies blurred regulatory lines, raised safety concerns, and ultimately triggered the warnings and enforcement actions that followed.
Together, the developments reinforce the FDA’s position that unapproved compounded GLP-1 drugs should not be marketed or promoted as alternatives to FDA-approved therapies.
References
@HimsHersComms, X (Twitter), https://x.com/HimsHersComms/status/2020207947645911214
Hims to stop offering GLP-1 pill after FDA warned of crackdown, Reuters, 08 February 2026, https://www.reuters.com/legal/litigation/hims-hers-stop-offering-compounded-semaglutide-pill-after-fda-crackdown-2026-02-07/