Hims & Hers Health announced that its pharmacy partner, Strive Pharmacy, would resume sales of its compounded GLP‑1 weight‑loss pill, a product that had been suspended after the U.S. Food and Drug Administration and the Department of Justice issued warning letters on March 3 2026 to 30 telehealth firms for misleading marketing claims about compounded GLP‑1s.
The warning letters cited violations of the Federal Food, Drug, and Cosmetic Act for marketing unapproved semaglutide formulations and for failing to provide adequate safety and efficacy data. Strive Pharmacy’s suspension was part of a broader FDA crackdown on mass‑marketed compounded GLP‑1 drugs, which the agency said could pose serious safety risks to patients.
Strive Pharmacy confirmed that sales of the compounded GLP‑1 pill resumed on March 4 2026, the day after the warning letters were issued. The company said it had taken corrective actions, including updating labeling, improving quality controls, and ensuring compliance with FDA guidance, to address the agency’s concerns. The resumption is expected to restore a significant portion of the weight‑loss segment’s revenue, which had been temporarily halted.
Hims & Hers’ weight‑loss business has been a key growth driver, contributing to a 49% year‑over‑year revenue increase to $599 million in Q3 2025 and a projected full‑year 2025 revenue of $2.335 billion to $2.355 billion. The company’s gross margin contracted to 74% in Q3 2025 from 79% in Q3 2024, largely due to higher‑cost personalized GLP‑1 offerings. Adjusted EBITDA rose to $78.4 million in Q3 2025 from $51.1 million in Q3 2024, reflecting disciplined cost management amid margin compression. Management has emphasized a shift toward non‑GLP‑1 offerings, noting that hormone therapies, menopause support, and diagnostics now generate the majority of cash flow.
Following the announcement, market participants reacted to the regulatory context and the company’s corrective steps. Analysts noted that while the resumption of sales mitigates immediate revenue loss, the ongoing FDA scrutiny and the recent Novo Nordisk patent infringement lawsuit could continue to weigh on investor sentiment. The company’s diversification strategy and strong non‑GLP‑1 revenue streams were highlighted as mitigating factors in the broader market assessment.
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