Novo Nordisk warns that Hims & Hers’ unapproved semaglutide pill is illegal mass compounding, raising patient safety concerns, as the company defends FDA-approved Wegovy pills and the US drug approval framework.
Written By: Sana Khan BPharm
Reviewed By: Pharmacally Editorial Team
Novo Nordisk has issued a strong statement responding to an announcement by Hims & Hers that it plans to mass-market an oral semaglutide product that Novo Nordisk says is unapproved, inauthentic, and unlawfully compounded.
According to Novo Nordisk, the move represents illegal mass compounding and raises serious patient safety concerns. The company said it will pursue legal and regulatory action to protect patients, its intellectual property, and the integrity of the US drug approval system.
Novo Nordisk also accused Hims & Hers of a pattern of misleading practices around GLP-1 products, noting that the U.S. Food and Drug Administration has previously warned the company about deceptive advertising related to compounded GLP-1 knock-offs.
Safety concerns around compounded GLP-1 products
The statement comes as leading medical bodies continue to caution against the use of compounded GLP-1 therapies. The American Diabetes Association’s Obesity Association recently published updated standards of care that discourage the use of compounded GLP-1 products, citing concerns around safety, quality, and effectiveness.
Compounded semaglutide products are not reviewed or approved by the FDA. Novo Nordisk warned that such products may contain impurities, unnecessary additives, or untested doses, all of which can expose patients to avoidable risks.
Wegovy pill and SNAC technology
Novo Nordisk emphasized that it is the only manufacturer of an FDA-approved oral semaglutide formulated with SNAC technology, which enables absorption of semaglutide when taken by mouth. This approved product is the Wegovy pill, which the company said is available in all doses and in full supply across the US.
The company reiterated that any compounded or “knockoff” semaglutide pill marketed outside the FDA approval framework does not meet the same standards for quality, safety, or clinical validation.
Protecting patients and the approval framework
Novo Nordisk framed the issue as broader than one company or product. It described the situation as a threat to patient trust and to the US “gold-standard” drug approval process, which is designed to ensure medicines are safe, effective, and manufactured to consistent quality standards.
The company said it will continue to take action to prevent the spread of unapproved semaglutide products and urged patients and healthcare providers to rely only on FDA-approved therapies when prescribing or using GLP-1 medicines.
References
Novo Nordisk issues statement on illegal mass compounding and deceptive advertising by Hims & Hers, 05 February 2026, News Details
More Options, More Support: New Compounded Semaglutide Pill from Hims & Hers, 05 February 2026, https://news.hims.com/newsroom/more-options-more-support-new-compounded-semaglutide-pill-from-hims-hers