The Spanish Agency of Medicines and Health Products (Aemps) has activated a new alert affecting one of the most widely used antidepressants in Spain. The Ministry of Health agency has ordered the immediate withdrawal of several batches of Duloxetine Pensa Pharma 60 mg after detecting “an impurity above the permitted limit”, a quality defect that, although “does not pose a vital health risk”, requires the withdrawal of all units.
The notification has set off alarm bells among patients who use this drug to treat depression, generalized anxiety or neuropathic pain. The Aemps wanted to make it clear that the measure is preventive and seeks to ensure that only drugs that meet all safety standards remain in circulation.
Affected lots: which Duloxetine presentations should be recalled
The packages involved correspond exclusively to Duloxetine Pensa Pharma 60 mg hard gastroresistant capsules EFG, manufactured by Towa Pharmaceutical.
The lots withdrawn are:
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Lot 231441 (expiration 6/30/2026) – Box of 28 capsules.
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Lot 231514 (expiration 05/31/2026) – Box of 56 capsules.
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Lot 240603 (expiration 11/30/2026) – Box of 56 capsules.
The Aemps has communicated the defect to all the autonomous communities and has implemented the protocol for immobilization and collection of the product in pharmacies, hospitals and health centers.
Instructions for patients: what to do if you have a container at home
Pharmacies have already been ordered to immobilize the affected containers and process them for return.
Patients should check their box of Duloxetine and check the lot number. If it matches any of the recalled ones, go to the pharmacy for replacement. However, if this is not the case, they cancontinue treatment with an unaffected box or follow medical indications.
The Aemps stresses that the impurity detected “does not imply a serious hazard”, but prevents the drug from meeting quality requirements, which is why it is withdrawn.
What is Duloxetine and what is it used for?
Duloxetine is an antidepressant that acts on two essential neurotransmitters: serotonin and noradrenaline. Its function is to stabilize mood and regulate emotional response, which makes it one of the most prescribed treatments for:
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Major depression.
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Generalized anxiety disorder.
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Diabetic neuropathic pain, a type of chronic pain caused by nerve damage.
Patients usually notice improvement after two weeks, although the full effect may take a month or more, especially when used to treat neuropathic pain.
Why is a drug withdrawn even if it does not pose a serious risk?
The impurity detected does not represent an urgent hazard, but it does imply that the drug “does not meet quality specifications”. Pharmaceutical safety standards require the recall of any batch that falls outside the expected parameters, even if the risk is low.
The recall affects patients who already had the drug at home, pharmacies that had these batches and healthcare centers that could have dispensed them. The Aemps applies this type of intervention systematically whenever a drug exceeds the limits allowed in its controls.
What are the alternatives for Duloxetine users?
Duloxetine is a frequently used drug, so physicians have protocols in place to replace affected containers with:
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Other boxes of the same drug not included in the alert.
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Therapeutic alternatives if necessary.
In no case should treatment be interrupted without prior consultation with a health professional, especially in patients with depression or anxiety disorders.
An advertisement focusing on quality control
This new episode highlights the importance of routine controls by the Spanish Medicines Agency, a task that ensures that pharmaceutical products strictly comply with safety parameters.
The recall of the Duloxetine batches does not respond to an immediate clinical risk, but to the need to maintain high quality standards in medicines that are part of the daily treatment of thousands of people.
