Curosurf Safety Information and Lot Recall

Detected March 19th, 2026

Summary

The French drug agency ANSM, in agreement with Laboratoire Chiesi SAS, has initiated a recall of one lot (Lot 1204229, Exp 04/2026) of Curosurf 120 mg/1.5 ml suspension for endotracheobronchial instillation. This precautionary measure follows a deviation observed during environmental monitoring at the production site.

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What changed

The French National Agency for Medicines and Health Products Safety (ANSM) has announced a precautionary recall of a specific lot (Lot 1204229, expiring April 2026) of Curosurf 120 mg/1.5 ml suspension for endotracheobronchial instillation, manufactured by Laboratoire Chiesi SAS. This action was taken due to a deviation identified during environmental monitoring of the production site, which has since been resolved. The recall is being conducted directly with the affected hospital establishments.

Healthcare providers administering Curosurf should be aware of this recall and ensure they do not use the affected lot. While the manufacturer states no pharmacovigilance cases have been reported in relation to this quality defect, the recall is a measure to prevent potential risks. Hospitals are expected to segregate and return or dispose of the recalled product according to laboratory instructions.

What to do next

Identify and segregate Curosurf Lot 1204229 (Exp 04/2026) in inventory.
Return or dispose of the recalled lot as per Laboratoire Chiesi SAS instructions.
Confirm with the laboratory that no affected product remains in use.

Source document (simplified)

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Niveau de rappel : directement auprès des établissements hospitaliers concernés Le Laboratoire Chiesi SAS procède, en accord avec l’ANSM et par mesure de précaution, au rappel du lot mentionné ci-dessous de la spécialité
- Curosurf 120 mg/1,5 ml, suspension pour instillation endotrachéobronchique - boîte de 1 flacon (CIP 34009 557 752 0 1)
Lot 1204229 (Exp 04/2026)
Ce rappel fait suite à une déviation désormais résolue, observée lors de la revue du suivi environnemental du site de production de la spécialité.

Le laboratoire précise qu'aucun cas de pharmacovigilance, en lien avec le défaut qualité, n'a été rapporté à ce jour.

Ce rappel de lot est effectué en direct auprès des établissements hospitaliers concernés.
Aucun numéro d'alerte n'a été attribué.