FDA record · warning letter

FDA warning letter: ProRx, LLC (Mar 4, 2025)

On Mar 4, 2025, FDA issued a warning letter to ProRx, LLC of Exton, PA under the subject "Compounding Pharmacy/Adulterated Drug Products". 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 ProRx, LLC
Field	What FDA’s record states	Source
Recipient	ProRx, LLC	FDA letter
Location	Exton, PA	FDA letter
Letter date	Mar 4, 2025	FDA letter
Posted by FDA	Mar 4, 2025	FDA index
Issuing office	Center for Drug Evaluation and Research (CDER)	FDA letter
Subject	Compounding Pharmacy/Adulterated Drug Products	FDA letter
MARCS-CMS number	696742	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

“Your facility’s drug products, such as Semaglutide 5mg/2ml (2.5mg/ml) 2ml, Tirzepatide 60mg/3ml (20mg/ml) 3ml, and Vancomycin 25mg/ml 10ml, did not include the following on the label: the statement “This is a compounded drug”; the name, address, and phone number of the applicable outsourcing facility; the established name of the drug; the dosage form; the statement “Office Use Only”; and a list of active and inactive ingredients, identified by established name and the quantity and proportion of each ingredient. 3.”FDA warning letter to ProRx, LLC, Mar 4, 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.

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