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 7, 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.

120 warning letters in our database

Mar 31, 2026 · #721805

Prime Sciences

Unapproved New Drugs Sold Over the Internet

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Mar 31, 2026 · #721600

Mile High Compounds LLC

Unapproved New Drugs Sold Over the Internet

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Mar 31, 2026 · #721088

Pink Pony Peptides

Lovega LLC

Unapproved New Drugs Sold Over the Internet

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Mar 31, 2026 · #721806

Gram Peptides

Unapproved New Drugs Sold Over the Internet

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Mar 5, 2026 · #717576

Novo Nordisk Inc.

Postmarketing Adverse Drug Experience Reporting Requirements

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Feb 20, 2026 · #717985

Zeuss

Zeuss 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 · #721448

Strut

Strut Health, LLC

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #721475

Refills Health

Refills Health, LLC

False & Misleading Claims/Misbranded

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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 · #721473

PharmaZee

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #721817

Peaks

Peaks Curative, LLC

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #721472

NewSelf

NewSelf Limited

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #721470

Newman Clinic

Newman Clinic, PLLC

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #721455

MEDVi

MEDVi, LLC

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #721453

Maxlife

MaxLife Technologies Inc.

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #717990

Levity

Levity Inc.

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 · #721450

Kin Meds

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 · #717986

Join Josie

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #721816

Ivim

Ivim Services LLC

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #721449

GoodGirlRX

Good Girl LLC

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #721451

Genesis

Genesis Health International Inc.

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #717987

FitRx

FitRX, LLC

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #717992

Amp Health

Dripgym Mobile Parent, LLC

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #721447

Deluxe IV and Aesthetics

Deluxe IV Aesthetics PLLC

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #721446

BluefitMD

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #721479

Bliv

Bliv Wellness LLC

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #721454

Measured

Better Health Labs, Inc.

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #721795

Belle

Belle Health LLC

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #721481

Fifty 410

Aspen Aesthetics

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #721814

Alan

Alan Health Technologies Inc.

False & Misleading Claims/Misbranded

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Feb 20, 2026 · #717984

24HrDoc

24HrDoc, Inc.

False & Misleading Claims/Misbranded

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Jan 20, 2026 · #718739

GenoGenix LLC

Compounding Pharmacy/Adulterated Drug Products

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Jan 16, 2026 · #717525

Boothwyn Pharmacy, 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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Oct 10, 2025 · #715795

PQ Pharmacy, LLC

Compounding Pharmacy/Adulterated Drug Products

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Sep 11, 2025 · #711330

Chengdu Brilliant Biopharmaceutical Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

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Sep 10, 2025 · #715595

Motionpharmacycom

Compounded GLP-1 marketing and labeling concerns

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Sep 9, 2025 · #

ybycmeds

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Vitals RX

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Tuyo Health

Tuyo Health, Inc.

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

TRYM Health

TRYM Health, Inc.

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Try Nova

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Sprout Health

Sprout Health Partners LLC

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Slendid

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

SimpleRx

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

SemaBio

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Reset IV

Reset IV, LLC

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Remedy Meds

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Nuvo Life Health

Nuvo Life Health Inc.

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #716495

Novo Nordisk Inc.

False & Misleading Claims/Misbranded

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Sep 9, 2025 · #

Medclub Dr Jenn

Compounded GLP-1 marketing and labeling concerns

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Sep 9, 2025 · #

Matthew Stern, CEO MyStart Health LLC.

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #715800

Master Pharmaceuticals Group

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Mane & Steel

Mane & Steel, LLC.

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Lyfe Rx

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Lumimeds

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Lovely Meds

Lovely Meds, Inc.

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

LeanDreams

Lean Dreams LLC

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Villas Health

Las Villas Health Care LLC

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

JulyMD

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

iVisitDoc

iVisitDoc, Inc.

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #715872

Invigorate Med Spa

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Intimate Rose

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Inspireclinic

Compounded GLP-1 marketing and labeling concerns

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Sep 9, 2025 · #

Hers

Hims & Hers Health, Inc.

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Hers

Hims & Hers Health, Inc.

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Healthy Male

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Healthy Living Clinic

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Healthon

Healthon Inc.

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

HealBerry

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Hcg Institute

Compounded GLP-1 marketing and labeling concerns

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Sep 9, 2025 · #

GLP-1 Solution

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Getfitmedical

Getfitmedical Llc

Compounded GLP-1 marketing and labeling concerns

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Sep 9, 2025 · #

GenLabMeds

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #716696

FWD

FWD Care, Inc.

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Zealthy

FitRX, LLC

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Fancy Meds

Fancy Meds, LLC

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Expert Aesthetics

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #715507

EvoLife Wellness

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #715869

Elite Health Center

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #716485

Eli Lilly and Company

False & Misleading Claims/Misbranded

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Sep 9, 2025 · #716475

Eli Lilly and Company

False & Misleading Claims/Misbranded

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Sep 9, 2025 · #716462

Eli Lilly and Company

False & Misleading Claims/Misbranded

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Sep 9, 2025 · #

Elevated

Elevate Your Wellness LLC,

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #716505

eDrugstore

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Trust Labs

EA WORKS Limited Liability Company

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Dr Gaters Weight Loss Wellness

Compounded GLP-1 marketing and labeling concerns

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Sep 9, 2025 · #

Directmeds

Directmedscom Inc

Compounded GLP-1 marketing and labeling concerns

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Sep 9, 2025 · #

Curex

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Cosmo Med Spa

Cosmo Medical Spa

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Canada Med Stop

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Body Good Studio

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Bioverse

Bioverse, Inc.

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

ASN-LABS

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

Amazing Meds

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Sep 9, 2025 · #

All American Wellness

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

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Jul 29, 2025 · #705501

cheaptrustedpharmacy.com

Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet

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Jun 12, 2025 · #706335

Wwwbuynetmedscom

Compounded GLP-1 marketing and labeling concerns

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May 5, 2025 · #703470

Wwwpeacefulmedscom

Compounded GLP-1 marketing and labeling concerns

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Apr 23, 2025 · #700358

Www24Hreupbiz

Compounded GLP-1 marketing and labeling concerns

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Apr 8, 2025 · #703497

Medivant Health

Tailstorm Health Inc.

Compounding Pharmacy/Adulterated Drug Products

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Mar 4, 2025 · #696742

ProRx, LLC

Compounding Pharmacy/Adulterated Drug Products

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Feb 26, 2025 · #696885

Usapeptidecom

Compounded GLP-1 marketing and labeling concerns

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Jan 13, 2025 · #695815

Wwwweightcrunchshopcom

Compounded GLP-1 marketing and labeling concerns

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Dec 10, 2024 · #694608

Xcel Research LLC

Unapproved New Drugs/Misbranded

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Dec 10, 2024 · #695663

Swisschems

Unapproved New Drugs/Misbranded

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Dec 10, 2024 · #695607

Summit Research Peptides

Unapproved New Drugs/Misbranded

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Dec 10, 2024 · #695156

Prime Peptides

Prime Vitality, Inc.

Unapproved New Drugs/Misbranded

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Sep 12, 2024 · #687590

Nomidabiz

Compounded GLP-1 marketing and labeling concerns

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Aug 20, 2024 · #674310

AnuMed International, LLC

Finished Pharmaceutical/Unapproved New Drug/Adulterated/Misbranded

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Jun 24, 2024 · #684435

Ozempencom

Compounded GLP-1 marketing and labeling concerns

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Apr 24, 2024 · #679727

Wwwdashpctcom

Compounded GLP-1 marketing and labeling concerns

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Feb 7, 2024 · #669074

US Chem Labs

CGMP/Finished Pharmaceuticals/Adulterated

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Feb 7, 2024 · #668918

Helix Chemical Supply

Synthetix Inc.

Unapproved New Drugs/Misbranded

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Oct 2, 2023 · #665848

Wwwsemaspacecom

Compounded GLP-1 marketing and labeling concerns

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Oct 2, 2023 · #664245

Wwwgorillahealingcom

Compounded GLP-1 marketing and labeling concerns

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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.