The Spanish Agency of Medicines and Health Products (Aemps) has issued a health alert classified as Class 2, ordering the immediate withdrawal from the market of multiple batches of an essential drug used in the treatment of depression, anxiety and diabetic neuropathic pain.
The product concerned is Duloxetine Pensa Pharma 60 mg hard gastroresistant capsules EFG manufactured by Towa Pharmaceutical Europe S.L.
Why has the antidepressant been withdrawn from the market?
The reason behind this preventive measure is due to the detection of a quality defect in the manufacturing process. Analyses of the drug identified an impurity that exceeds the safety and quality limits established for this active ingredient.
Duloxetine acts by increasing the levels of the neurotransmitters serotonin and noradrenaline in the nervous system. Although this situation does not pose an imminent life-threatening risk to patients, the Class 2 classification indicates that the production defect is significant enough to require immediate stoppage of the drug’s distribution.
Which batches of the drug are affected
Pharmaceutical companies and wholesalers are obliged to recall from the market all distributed units of the specified batches and return them directly to the manufacturing laboratory, Towa Pharmaceutical Europe. This recall is required as a preventive measure to ensure the safety of the drug and to prevent defective units from being dispensed to the public.
The specific lots to be recalled are:
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Lot 231441 (Presentation of 28 capsules, Expiration: 06/30/2026)
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Lot 231514 (Pack of 56 capsules, Expiration: 05/31/2026)
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Lot 240603 (Pack of 56 capsules, Expiration: 11/30/2026)
Recommendations for patients under treatment
The Aemps has issued direct recommendations to consumers currently taking Duloxetine Pensa Pharma 60 mg from the affected lots.
Patients are advised to visit their physician or pharmacist as soon as possible to review their treatment: the aim is to enable healthcare professionals to determine an appropriate therapeutic alternative or to replace the affected units with others that are not included in the health alert.
