FDA record · warning letter

FDA warning letter: Sprout Health Partners LLC dba Sprout Health (Sep 9, 2025)

On Sep 9, 2025, FDA issued a warning letter to Sprout Health Partners LLC dba Sprout Health under the subject "Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)". It names semaglutide, tirzepatide. Open: no closeout letter published as of Oct 3, 2026.

Julian CaraulaniFounder, PriceTracker GLP-1FDA record read Oct 3

Status: Open: no closeout letter published as of Oct 3, 2026.

What FDA’s record states

FDA record for the warning letter to Sprout Health Partners LLC dba Sprout Health
Field	What FDA’s record states	Source
Recipient	Sprout Health Partners LLC dba Sprout Health	FDA letter
Location	Not published by FDA	n/a
Letter date	Sep 9, 2025	FDA letter
Posted by FDA	Sep 16, 2025	FDA index
Issuing office	Center for Drug Evaluation and Research (CDER)	FDA letter
Subject	Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)	FDA letter
MARCS-CMS number	715879	FDA letter
GLP-1 drugs named	Semaglutide, Tirzepatide	FDA letter
Response letter	Not published by FDA	FDA letter
Closeout letter	Not published by FDA	FDA letter

“As described below, your claim concerning compounded semaglutide and tirzepatide products is false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].”FDA warning letter to Sprout Health Partners LLC dba Sprout Health, Sep 9, 2025 · read the full letter on fda.gov ↗

What this is and is not.A warning letter is FDA’s statement of what it considers significant violations. It is an allegation, not a court finding, and the firm can respond. A closeout letter is posted when FDA confirms the violations were corrected.

A program we track

Sprout Health appears on our price board. Its page shows what it charges and what we verified about it, including this record. Sprout Health: prices and checks

Other GLP-1 letters FDA issued that week

And 48 more in the full list.

Source

Every field above is copied from FDA’s page for this letter, read Oct 3, 2026. The letter on fda.gov ↗ · All 161 GLP-1 warning letters