PriceTracker GLP-1

FDA record · warning letter

FDA warning letter: Healthy Male (Sep 9, 2025)

On Sep 9, 2025, FDA issued a warning letter to Healthy Male of Tempe, AZ 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 Healthy Male
FieldWhat FDA’s record statesSource
RecipientHealthy MaleFDA letter
LocationTempe, AZFDA letter
Letter dateSep 9, 2025FDA letter
Posted by FDASep 16, 2025FDA index
Issuing officeCenter for Drug Evaluation and Research (CDER)FDA letter
SubjectUnlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)FDA letter
MARCS-CMS number716506FDA letter
GLP-1 drugs namedSemaglutide, TirzepatideFDA letter
Response letterNot published by FDAFDA letter
Closeout letterNot published by FDAFDA letter
“McClintock Drive Suite 107 Tempe , AZ 85283 United States smedicalaz@gmail.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER September 9, 2025 Healthy Male: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://healthymale.com in August 2025 and has observed that your website offers various compounded drug products, including tirzepatide.”FDA warning letter to Healthy Male, 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.

Other GLP-1 letters FDA issued that week

Chengdu Brilliant Biopharmaceutical Co., Ltd.Sep 11, 2025motionpharmacy.comSep 10, 2025All American WellnessSep 9, 2025Amazing MedsSep 9, 2025ASN-LABSSep 9, 2025Bioverse, Inc. dba BioverseSep 9, 2025Body Good StudioSep 9, 2025Canada Med StopSep 9, 2025Cosmo Medical Spa dba Cosmo Med SpaSep 9, 2025CurexSep 9, 2025directmeds.com, Inc. dba DirectMedsSep 9, 2025Dr. Gater’s Weight Loss & WellnessSep 9, 2025

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