Editorial Database

FDA Warning Letters: Compounded GLP-1 Telehealth Providers

An independently maintained, primary-source compilation of FDA warning letters issued to telehealth companies marketing compounded semaglutide, tirzepatide, and other GLP-1 products. Every entry links to the original letter on fda.gov.

Data as of April 6, 2026 · Report a missing letter

What this database is — and what it isn't

An FDA warning letter is the agency's principal means of notifying a company that the agency considers one or more of its products, practices, or marketing claims to be in violation of the Federal Food, Drug, and Cosmetic Act. The letter is a public document and appears on fda.gov.

A warning letter is not a recall, a fine, a criminal charge, or a finding of illegal activity. It is the start of a regulatory conversation. Companies typically have 15 working days to respond, and FDA may issue a close-out letter once the agency is satisfied that the cited issues have been corrected.

We compile these letters because they are the best public signal of which compounded-GLP-1 telehealth companies have drawn FDA scrutiny. We do not editorialize about whether a company is "bad." We quote FDA language and link to the source.

17 warning letters in our database

Mar 5, 2026 · #717576

Novo Nordisk Inc.

Postmarketing Adverse Drug Experience Reporting Requirements

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Feb 20, 2026 · #717986

Join Josie

Compounded GLP-1 marketing and labeling concerns

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Feb 20, 2026 · #717987

FitRx

FitRx LLC

Compounded GLP-1 marketing and labeling concerns

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Feb 20, 2026 · #721450

Kin Meds

Compounded GLP-1 marketing and labeling concerns

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Feb 20, 2026 · #721454

Measured

Better Health Labs Inc

Compounded GLP-1 marketing and labeling concerns

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Feb 20, 2026 · #721475

Refills Health

Refills Health LLC

Compounded GLP-1 marketing and labeling concerns

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Feb 20, 2026 · #721446

BlueFitMD

Compounded GLP-1 marketing and labeling concerns

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Feb 20, 2026 · #721474

Premium Health

Premium Health Management Inc.

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #717991

Zappy

Kare Solutions, LLC

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #717989

SkinnyRx

Lean Rx, Inc.

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #721448

Strut

Strut Health, LLC

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #721478

WeightCare

Weightless Medical LLC

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #721818

VIV RX

Viv Health, Inc.

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #717985

Zeuss

Zeuss LLC

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #721816

Ivim

Ivim Services LLC

False & Misleading Claims/Misbranded

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Jan 20, 2026 · #718739

GenoGenix LLC

Compounding Pharmacy/Adulterated Drug Products

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Dec 1, 2025 · #717972

Apothecary Pharma, LLC

Compounding Pharmacy/Adulterated Drug Products

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How to read an FDA warning letter

Each FDA warning letter follows a standard structure: an opening paragraph identifying the company and the violations FDA is alleging, a numbered list of specific concerns (citing the relevant FDCA sections), and a closing paragraph explaining what the company must do to respond.

For compounded GLP-1 letters, the most common citations are under FDCA section 503A (the framework for traditional 503A compounders) and section 503B (for outsourcing facilities). Letters often reference unapproved new drug claims, misbranding, or use of bulk drug substances not on FDA's approved list.

A warning letter is the start, not the end, of an FDA enforcement process. We track status on each letter — "active" means the letter has not been formally closed out by FDA. We update entries when FDA publishes a close-out letter or withdraws the warning.

Editorial Disclaimer

FDA warning letters are public regulatory communications and do not, on their own, indicate that a company has done anything illegal. Companies often respond to warning letters with corrective action, and many letters are eventually closed out. We compile this database as a public service and link to the original FDA letter for every entry. If you believe an entry here is inaccurate or out of date, please contact us.