Cipla's US Recall Triggers Lanreotide Shortage

Cipla USA Inc., a wholly owned subsidiary of

., has initiated a voluntary recall of unexpired batches of Lanreotide injection, a critical oncology drug. This action stems from the US FDA classifying its partner Pharmathen International S.A.'s Greek facility as Official Action Indicated (OAI) after a November 2025 inspection that uncovered nine Form 483 observations, including contamination risks, aseptic process failures, and data integrity concerns.​ The recall creates a temporary US market shortage for Lanreotide, Cipla's largest product there with a 22% market share as of Q2 FY26. No production is currently underway at the facility amid remediation efforts; management anticipates resumption by Q4 FY26, pending regulatory approval, though some analysts project delays into H1 FY27.​ Cipla now foresees a tough Q4 FY26 without Lanreotide or generic Revlimid sales, alongside revised EBITDA margin guidance to 21% from 22.5%. Disclaimer: This post is for informational purposes only and not a recommendation to buy or sell any securities. I, or my family, associates, or relatives, may have a financial interest in the securities mentioned.