Hims & Hers Stock Plunges after FDA Warning on Compounded Weight-Loss Drug

Lead Shares of Hims & Hers Health (NYSE: HIMS) tumbled more than 7% on September 16, 2025, after the U.S. Food and Drug Administration issued a warning letter over the company’s marketing of compounded semaglutide products for weight loss.

Nut Graf The decline underscores investor concern that regulatory scrutiny of Hims & Hers’ compounded offerings could hinder one of its fastest-growing segments and weigh on revenue momentum.

Market Reaction Subhead: Stock Performance

Opened at $54.32 and closed at $50.40, a 7.2% drop.
Intra-day high of $54.34 and low of $48.69 on unusually heavy trading volume of 29.4 million shares.

Subhead: FDA Warning Details

Letter dated September 9 alleges that Hims & Hers’ claims imply equivalence to FDA-approved products.
FDA cited violations of the Federal Food, Drug, and Cosmetic Act and demanded corrective action or face legal consequences.

Business Impact Subhead: Compounded Semaglutide Segment

Hims & Hers has rapidly expanded into generic weight-loss therapies, leveraging compounding to offer lower-cost alternatives.
Regulatory pushback threatens to delay new product launches and may erode consumer trust.

Subhead: Broader Regulatory Climate

The FDA dispatched roughly 100 warning letters this week to online drug advertisers, signaling heightened oversight of telehealth platforms.
Other telemedicine firms also face increased scrutiny on marketing and labeling practices.

Looking Ahead

Investors will watch for Hims & Hers’ response to the FDA letter and any revisions to marketing materials.
Monitoring upcoming quarterly results will be critical to gauge the financial impact of compliance costs and potential slowdown in the weight-loss business.