Hims & Hers Faces FDA Warning

FDA Cracks Down on Hims & Hers Over Deceptive GLP-1 Marketing

The FDA issued a warning letter to Hims & Hers Health, Inc. on September 9, 2025, citing false and misleading claims concerning compounded semaglutide products on the forhers.com website [1]. The regulatory agency specifically targeted claims such as "Weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy" and "Clinically proven ingredients," stating these representations are misleading because compounded drugs are not FDA-approved [2].

This FDA action has triggered a wave of legal challenges against the telehealth company. Several law firms, including Levi & Korsinsky, The Gross Law Firm, Hagens Berman, and The Rosen Law Firm, each filed securities class action lawsuits against Hims & Hers in June 2025, with a lead plaintiff deadline of August 25, 2025 [3].

Securities Fraud Allegations Rock Hims & Hers Stock

The class action lawsuit targets investors who purchased Hims & Hers Health, Inc. (NYSE: HIMS) shares between April 29, 2025, and June 23, 2025 [4]. The lawsuit alleges that Hims & Hers made false and misleading statements and failed to disclose that the company was engaged in the deceptive promotion and selling of illegitimate, knock-off versions of Wegovy, which put patient safety at risk [5].

Investors also claim there was substantial risk that the company's collaboration with Novo Nordisk would be terminated, information that was allegedly withheld from shareholders. The securities litigation highlights the financial risks companies face when making unsubstantiated medical claims about compounded medications.

Consumer Protection Investigation Targets Marketing Violations

Zimmerman Reed LLP, in partnership with Tycko & Zavareei LLP, is investigating whether Hims & Hers violated consumer protection laws and FDA regulations regarding the marketing of compounded semaglutide injections. This investigation focuses specifically on whether Hims & Hers misrepresented its compounded semaglutide products as having "clinically proven ingredients" and the "same active ingredient as Ozempic and Wegovy."

The law firm Tycko & Zavareei LLP has a proven track record, having recovered over $600 million in complex litigation and mass arbitration cases. This investigation could potentially lead to significant consumer compensation for individuals who purchased and used compounded semaglutide products from Hims & Hers through hims.com or forhers.com.

FDA Safety Concerns Mount Over Compounded GLP-1 Products

The FDA has expressed significant concerns about the safety and effectiveness of compounded semaglutide products. In April 2024, the agency warned that some compounded semaglutide products contain salts and impurities, unlike the approved formulations, and may be less safe and effective [9].

The adverse event reports are alarming. As of July 31, 2025, the FDA had received 605 reports of adverse events associated with compounded semaglutide and 545 reports of adverse events associated with compounded tirzepatide. Between February 2019 and December 2023, the FDA received 352 adverse event reports related to compounded GLP-1 drugs, including five deaths.

In 2023 alone, poison centers reported nearly 3,000 calls involving semaglutide, representing a more than 15-fold increase since 2019. These statistics underscore the growing public health concerns surrounding unregulated compounded versions of these medications.

Novo Nordisk's Legal Offensive Against Compounders

Novo Nordisk, the maker of Ozempic and Wegovy, has launched an aggressive legal campaign against companies marketing compounded semaglutide. As of August 2025, Novo Nordisk had filed over 130 cases in 40 U.S. states, alleging trademark infringement and false advertising [10].

In one notable case, Novo Nordisk filed suit against LifeRxMd on September 6, 2024, alleging trademark infringement and false advertising. Courts have been fairly consistent in granting Novo Nordisk preliminary injunctions, which temporarily stop defendants from using Ozempic and Wegovy trademarks to promote their compounded semaglutide products.

Novo Nordisk has publicly expressed concerns about the safety of compounded GLP-1 drugs, stating that some vials have been found to contain dangerous impurities, banned substances, or incorrect doses.

Severe Side Effects Drive Personal Injury Claims

Common side effects of GLP-1 agonists include reduced appetite, nausea, vomiting, diarrhea, headaches, and dizziness [11]. However, more severe side effects that are the subject of lawsuits include gastroparesis, ileus, vision changes, and blood clots.

The FDA initiated further investigation in January 2024 of the potential risk of suicidal ideation and behavior (SI/B) for GLP-1 RA medications, though an initial review of clinical trial data did not find an association between the use of GLP-1 RAs and the occurrence of suicidal thoughts or behaviors.

The FDA has issued warnings about counterfeit Ozempic found in the U.S. drug supply chain. In December 2025, the FDA advised consumers and pharmacies to check for products and ensure they are only obtaining Ozempic with a valid prescription through state-licensed pharmacies. One counterfeit product displayed a combination of lot number PAR0362 and illegitimate serial numbers that begin with the following eight digits: 51746517. In January 2026, Congressman Raja Krishnamoorthi sent letters to Chinese biotechnology companies regarding illicit and potentially dangerous counterfeit GLP-1 manufacturing threatening the U.S. drug supply.

Company Responses and Market Impact

Following the FDA warning letter, Hims & Hers stated that their website and customer-facing materials note that compounded treatments are not approved or evaluated by the FDA. Hims & Hers CEO Andrew Dudum stated that the company shares the FDA's commitment to ensuring individuals can make informed choices about their care.

The legal challenges and regulatory scrutiny have significant implications for the telehealth industry's marketing practices. The increasing number of claims may drive company settlements, label changes, increased regulatory scrutiny, and impact how emerging drugs are marketed and monitored.

As this litigation continues to evolve, affected individuals who have used compounded semaglutide products or experienced adverse effects from GLP-1 medications should consult with qualified legal counsel to understand their rights and potential compensation options.