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Novo Nordisk recently filed 14 new lawsuits intended to protect patients from unapproved compounded drugs that falsely claim to contain semaglutide. The defendants that are mentioned in the lawsuits claim that these compounded products have been both reviewed and approved by the FDA, or are just as effective as manufacturer’s approved semaglutide products.

Telehealth providers accused of steering patients toward unsafe products

According to the lawsuits, telehealth providers are infringing upon state corporate practice of medicine laws by not only unfittingly impacting doctors' decisions, but guiding patients to take the counterfeit compounded semaglutide. These products have reportedly unapproved knockoffs not been approved as safe and effective, and have potentially been created using banned foreign active pharmaceutical ingredients (APIs).

"Patients deserve safe, effective treatments from companies they can trust. No one should have to gamble with their health by using knockoff drugs made with ingredients that lack oversight and safety standards," said Dave Moore, executive vice president, US Operations of Novo Nordisk Inc. "Novo Nordisk is addressing this issue through education, advocacy, and legal action against businesses that mislead Americans and jeopardize their health with unsafe and unapproved knockoffs. We urge regulators to enforce laws designed to protect public health."

Complaints filed across 40 states as part of broader legal strategy

So far, Novo Nordisk has filed 132 federal complaints across 40 states, targeting companies whose unlawful marketing and business practices may jeopardize patient safety.

The company is also focusing its legal actions on two main stakeholders:

1. Pharmacies manufacturing unapproved compounded semaglutide drugs under the appearance of personalization that is in violation of state law.
2. Telehealth companies where corporations (as opposed to doctors), unfittingly guide patient care to these compounded semaglutide drugs by making fake personalization claims of personalization, which is a violation of California law.

Courts issue permanent injunctions and financial penalties

Courts have already granted 44 permanent injunctions in similar cases, barring defendants from engaging in illegal activities, such as unlawfully compounding semaglutide and falsely marketing these products as FDA-approved, safe, or equivalent to Novo Nordisk’s branded medications like Wegovy and Ozempic. In fact, back in June, Novo terminated its partnership with Hims & Hers² over claims that the company had been selling counterfeit versions of Wegovy and had “failed to adhere to the law which prohibits mass sales of compounded drugs under the false guise of "personalization" and are disseminating deceptive marketing that put patient safety at risk.”

Further, courts have ordered defendants to give up any profits that were made via these various practices.

FDA warnings highlight real patient safety risks

The FDA has issued multiple alerts, advising patients and HCPs alike on the about the hazards of these counterfeit drugs. There were even reports of patients who overdosed by incorrectly administering five to 20 times the intended dose, requiring hospitalization as a result.

Novo Nordisk's federal lawsuits filed by state. Image Credit: Novo Nordisk

Noom continues to market compounded semaglutide at lower doses

Meanwhile, Reuters earlier this week confirmed³ that Noom, an online weight loss company, would continue to sell its compounded semaglutide moving forward. It would be at aforementioned 0.6-milligram dose, as opposed to Novo’s version of 2.4 milligrams. The company introduced its Microdose GLP-1^Rx Program, a service intended to limit side effects via personalized microdoses of GLP-1s, when clinically appropriate.

Microdoses are considered fractions of the standard medication doses, 25% or less. Noom’s data has shown that members have lost up to 11 pounds in 30 days and up to 17 pounds in 60 days by taking these microdoses.³

“In the Microdose GLP-1^Rx Program, we set out to virtually eliminate side effects for the vast majority, so that more than 70% of people would encounter no side effects. In both my clinical experience and evidence in published studies, it is clear that many people discontinue GLP-1 treatment because of side effects,” commented Dr. Jeffrey Egler, Noom’s chief medical officer. “The Noom Microdose GLP-1^Rx Program was designed to address this issue by introducing GLP-1s gradually and sustaining them at a microdose level, as part of a larger holistic behavior change platform, which we call our GLP-1 Companion. This approach helps more patients stay on the treatment, experience the full health benefits of these medications, and make real progress in reducing obesity and overweight rates in the United States.”

Novo Nordisk warns of unregulated APIs and launches public awareness campaigns

However, according to Novo, there is independent data that highlights the threats posed by these compounded semaglutide products. For one, a recent Brookings Institution¹ report explains that many compounded semaglutide products rely on synthetic API imported from facilities in China that could lack FDA oversight or quality controls. Sixty percent of Chinese manufacturers importing this semaglutide for compounding use or further manufacture are not legally allowed to distribute that API in China for utilization in human drugs.

The manufacturer has debuted various educational campaigns such as "Check Before You Inject" and "Choose The Real Thing" that are intended to inform the public on the risks associated with unapproved knockoffs. Also, semaglutide.com can educate patients on the dangers of compounded and counterfeit products, along with where to go for FDA-approved treatments.

References

1. Novo Nordisk Expands Legal Action to Protect US Patients From Unsafe, Non-FDA-Approved Compounded "Semaglutide.”. PR Newswire. August 5, 2025. Accessed August 6, 2025. https://www.prnewswire.com/news-releases/novo-nordisk-expands-legal-action-to-protect-us-patients-from-unsafe-non-fda-approved-compounded-semaglutide-302522326.html

2. Novo Nordisk Terminates Collaboration With Hims & Hers Health, Inc. Due to Concerns About Their Illegal Mass Compounding and Deceptive Marketing. PR Newswire. June 23, 2025. Accessed August 6, 2025. https://www.prnewswire.com/news-releases/novo-nordisk-terminates-collaboration-with-hims--hers-health-inc-due-to-concerns-about-their-illegal-mass-compounding-and-deceptive-marketing-302488189.html

3. Saraceno N. Noom Debuts Microdose GLP-1 Program to Help Reduce Side Effects and Boost Affordability. Pharmaceutical Commerce. August 5, 2025. Accessed August 6, 2025. https://www.pharmaceuticalcommerce.com/view/noom-microdose-glp-1-program-reduce-side-effects-boost-affordability