Class II recall
Compounded tirzepatide voluntary recall, September 2025
Compounded tirzepatide · Announced 2025-09-08 · Last reviewed May 2026
Reviewed by the glpzoom Editorial Team against primary clinical sources — FDA labeling, peer-reviewed trials, and specialty-society guidelines.
Content current as of May 2026; updated when guidance or availability changes.
Following FDA inspection findings, multiple 503A pharmacies voluntarily recalled compounded tirzepatide products distributed between April and August 2025. Findings included inconsistent active-ingredient concentration (potency variability between batches) and in two cases potential sterility concerns with reused syringes during compounding. No confirmed patient harm was reported, but affected patients were instructed to stop using identified lots and return them to the dispensing pharmacy. Many telehealth platforms which sourced compounded tirzepatide either transitioned patients to brand-name Zepbound or paused new compounded tirzepatide prescriptions.
What's affected
- Specific lot numbers vary by compounding pharmacy — check labels and dispensing-pharmacy notices
- Affected vials distributed April-August 2025 from impacted pharmacies
- Patients usually receive direct notification from their dispensing pharmacy if affected
What patients should do
- Stop using affected lot numbers immediately if notified by your pharmacy
- Contact your prescriber to arrange transition to brand-name Zepbound or to a different pharmacy
- If you experience injection-site infection, abscess, or fever, seek medical care promptly
- Report adverse events related to the recalled product to FDA MedWatch