Pharmacy evidence record · researched 2026-08-20
ProRx, LLC
FDA warning letters identify semaglutide products and recalls.
FDA warning letters identify tirzepatide products/recalls and state that certain tirzepatide bulk-substance compounding was ineligible for section 503B exemptions.
Product evidence does not establish current availability.
Regulatory compliance
A pathway label describes which federal rules apply — it is not a quality claim.
Section 503A
not supported
Section 503B
FDA warning letters treat ProRx as an outsourcing facility under section 503B, while the current weekly registry check did not return ProRx. Current registration is not asserted.
Telehealth providers
Clinic Scout links a provider only when an explicit source names the relationship.
Regulatory history
FDA warning-letter, Form 483, recall/current-503B sources were checked. State-board actions were not independently verified.
U.S. Food and Drug Administration · 2024-08-02
ProRx / acknowledged by FDA · 2024-08-22
Recall of sterile products within expiry due to lack of sterility assurance; FDA warning materials identify semaglutide and tirzepatide products.
Status not statedU.S. Food and Drug Administration · 2024-12-20
FDA cited failures to meet section 503B conditions, insanitary conditions/CGMP deficiencies, unapproved drugs and misbranding.
Status not statedU.S. Food and Drug Administration · 2025-09-19
ProRx / acknowledged by FDA · 2025-10-15
Recall of tirzepatide and semaglutide multidose-vial lots due to lack of sterility assurance.
Status not statedU.S. Food and Drug Administration · 2026-04-07
FDA cited tirzepatide bulk-substance compounding that was ineligible for section 503B exemptions, labeling/adverse-event failures, insanitary conditions and CGMP violations.
Status not statedNo Clinic Scout patient reviews are published for this pharmacy. Submissions go through manual moderation before anything appears here.
What this record verifies for you
Each line traces to a citation in the source list below — read the exact captured wording before relying on it.
No superiority claim is made for review volume, ratings, or patient sentiment.
ProRx Pharma is an FDA-registered 503B facility focused on providing essential compounded sterile and non-sterile preparations.
Your facility's drug products, such as Semaglutide 5mg/2ml (2.5mg/ml) 2ml, Tirzepatide 60mg/3ml (20mg/ml) 3ml ... did not include ... the statement 'This is a compounded drug'
FDA also acknowledges that on August 22, 2024, your firm initiated a voluntary recall of drug products intended or expected to be sterile, within expiry, due to lack of sterility assurance.
These drug products compounded using tirzepatide bulk drug substance are not eligible for the exemptions provided by section 503B because tirzepatide does not appear on the 503B bulks list
On October 15, 2025, your firm initiated a voluntary recall of Lot PRORX08062025-3 of Tirzepatide Injection 27mg/3mL ... and various lots of Semaglutide Injection multidose vials ... due to a lack of sterility assurance.
State licenses listed: Arizona, Colorado, Connecticut, Georgia, Hawaii, Idaho, Illinois, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, North Carolina, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Texas, Utah, Washington, Washington D.C., West Virginia
Updated as of 8/18/2026 ... This table lists the outsourcing facilities that have submitted registration information that has been determined to be complete by the data lock date for the latest weekly update of the table.
GLP Clinic Scout does not issue a blanket legitimacy verdict. This research record preserves 7 dated first-party or regulator citation(s), 6 regulatory/action record(s), and 5 explicitly unresolved field(s). Review the cited evidence and current license status before making a decision.
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