Spain’s medicines agency has ordered a recall of multiple lots of Bilaxsten 6mg/ml eye drops, a common treatment for allergy symptoms, effective February 24, 2026. The Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) cited the detection of subvisible particles in the active ingredient as the reason for the withdrawal.
The recall affects a wide range of lot numbers and expiration dates, extending into early 2028. Specifically, lots 284720A and 284720B, both expiring March 31, 2026, are included, as are lots 286360A, 286370A and 286400A, all with a March 31, 2026, expiration date. Further affected lots include 295610B (expiring June 30, 2026), 312530A, 312540A, and 313190A (all expiring December 31, 2026), 322210A and 322320A (expiring April 30, 2027), and 342600B, 342601B, and 342910A (all expiring January 31, 2028).
The AEMPS classifies the defect as a Class 2 issue, indicating a potential risk but not one immediately life-threatening to patients. The agency has instructed distributors to remove all affected units from the market and return them to the manufacturer, FAES FARMA, S.A. Manufacturing is carried out by FAMAR HEALTH CARE SERVICES MADRID S.A.U.
This recall is an expansion of a previous pharmaceutical alert, R_16/2025, according to the AEMPS. The agency has directed regional health authorities to monitor the withdrawal process. The identified defect relates to specifications regarding subvisible particles within the active ingredient, detected during stability studies.
The AEMPS has made a detailed informational note available to the public for further information regarding the recall.
