Class II recall
ProRx LLC recalls compounded semaglutide and tirzepatide (October 2025)
Compounded semaglutide and tirzepatide (ProRx LLC) · Announced 2025-10-15 · Last reviewed July 2026
Reviewed by the WeighedHealth Editorial Team against primary clinical sources — FDA labeling, peer-reviewed trials, and specialty-society guidelines.
Content current as of July 2026; updated when guidance or availability changes.
In October 2025, compounder ProRx LLC initiated a voluntary nationwide recall of lots of its compounded semaglutide and tirzepatide injectable products due to lack of sterility assurance identified during inspection. Recalled lots and distribution details are listed in the FDA Enforcement Report database. Non-sterile injectables carry a risk of injection-site and bloodstream infections. Patients with affected lots were instructed to stop use and contact their dispensing pharmacy; no confirmed patient harm had been reported at announcement.
What's affected
- ProRx LLC compounded semaglutide and tirzepatide injectable lots listed in the FDA Enforcement Report
- Patients and telehealth programs supplied by ProRx during the affected window
What patients should do
- Check your vial's pharmacy label — if dispensed by ProRx LLC, compare the lot against the FDA Enforcement Report listing
- Stop using affected lots and contact your dispensing pharmacy for return/replacement instructions
- If you experience injection-site infection, abscess, or fever, seek medical care promptly
- Report adverse events to FDA MedWatch