Class II recall

Compounded semaglutide voluntary Class II recall, April 2026

Compounded semaglutide · Announced 2026-04-12 · 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 of inconsistent dose-to-dose potency in compounded semaglutide vials, multiple 503A compounding pharmacies have issued voluntary Class II recalls covering specified lots. The FDA classifies this as Class II, meaning the products may cause temporary or medically reversible adverse health consequences (under- or over-dosing during titration). Patients currently using compounded semaglutide should check their vial labels against the affected lot lists published by their dispensing pharmacy and follow up with their prescriber to verify their current vial is unaffected or to arrange replacement.

What's affected

Specific lot numbers vary by compounding pharmacy
Affected vials typically dispensed Q4 2025 through Q1 2026
Patients receive recall notices directly from dispensing pharmacy when their lot is affected

What patients should do

Check vial label against your dispensing pharmacy's published affected lot list
Do not stop treatment without consulting your prescriber
If affected, follow pharmacy instructions for replacement or return; bridge with branded if possible during gap
Report any unexpected dose effects to prescriber and to FDA MedWatch

For clinicians

Review patient lot numbers at next visit; consider switch to branded semaglutide if compounded sourcing is in question; document lot tracking for any patient reporting dose-effect inconsistency.