ANSM recalls Ganirelix Theramex batch over impurity — 7 October 2026

France’s medicines regulator ANSM announced a pharmacy- and distribution-level recall of one batch of Ganirelix Theramex after stability studies identified an impurity above the acceptable limit.

Products affected

• Product: Ganirelix Theramex 0.25 mg/0.5 mL solution for injection in a pre-filled syringe, pack of five
• CIP: 34009 302 381 6 5
• Batch: 250208
• Expiry: 04/2029
• Recall level: pharmacies and the pharmaceutical distribution circuit

Reason and safety context

ANSM states that the recall follows the detection, during stability studies, of an impurity above the acceptable limit. At the date of the communication, no pharmacovigilance case associated with the quality defect had been reported, and no supply difficulty was anticipated.

This is a batch-specific regulatory action. It should not be interpreted as evidence of a quality concern affecting the manufacturer’s or marketing authorisation holder’s entire product portfolio.

Operational relevance for pharmacovigilance teams

QPPVs, LQPPVs and LPPVs should assess local exposure to the affected batch, confirm distribution-channel notifications and recall completion, and review any related product-quality complaints or safety reports in accordance with local procedures.

Official source: ANSM product recall MED 26/A021, published 6 October 2026.

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Disclaimer. This material is provided solely for information and pharmacovigilance purposes, based on the official communication issued by ANSM and current as of 6 October 2026. It is not medical or legal advice, does not replace the official source, and does not imply wrongdoing by the manufacturer/marketing authorisation holder or a quality concern affecting the company’s entire product portfolio. Company and product names are used only to identify the official material accurately. Decisions should be based on the primary source, the regulator’s instructions and the approved product information.