A large-scale recall campaign has begun in pharmacies across Spain for specific batches of the medication Duloxetine Pensa Pharma 60 mg. The reason for the recall is a detected impurity found at a level exceeding the allowed standard. Although there is no immediate threat to patients’ lives, specialists have decided on an immediate recall to eliminate any potential health risks.
Three batches are affected: 231441 (expiration date June 30, 2026, 28 capsules), 231514 (expiration date May 31, 2026, 56 capsules), and 240603 (expiration date November 30, 2026, 56 capsules). All were produced by Towa Pharmaceutical and distributed through official channels. Medical facilities and pharmacies have already received instructions on returning the products, and patients are being asked to check their packages and return them to a pharmacy if needed.
Reasons for the recall
The medication was found to contain an impurity exceeding established limits. This is considered a quality defect that should not occur in drugs intended to treat depression, anxiety disorders, and pain from diabetic neuropathy. While experts emphasize that the detected impurity does not pose a life-threatening risk, precautionary measures require the immediate recall of all affected packages.
The manufacturer and distributors have already begun the return process. Patients who have packs with the listed batch numbers at home are advised not to use them and to take them to the nearest pharmacy. Pharmacists will accept the medication and arrange for its return according to the established procedure.
What patients need to know
Duloxetine is a medication from the group of serotonin and norepinephrine reuptake inhibitors. It is prescribed for depression, generalized anxiety disorder, pain from diabetic neuropathy, and fibromyalgia. The drug comes in delayed-release capsules to protect the active ingredient from being destroyed in the stomach.
If you have a package of Duloxetine Pensa Pharma 60 mg, carefully check the batch number and expiration date. If they match any of the numbers listed above, do not take the medication and contact your pharmacy. Doctors and pharmacists are available to advise you on replacement or return options.
Return procedure
The return process is simple: just bring the package to a pharmacy, where the pharmacist will process the return and provide further instructions. Medical institutions have also received guidelines for returning the affected batches through internal channels. It is important to note that this recall is a precaution and is not related to any reported cases of poisoning or serious side effects.
Authorities emphasize that the situation is under control, and patients have no cause for concern if they follow specialists’ recommendations. All other batches not included in the recall remain available and are considered safe for use.
In case you didn’t know, AEMPS is the government agency responsible for overseeing the quality of medicines and medical devices in Spain. The agency regularly conducts inspections and monitors pharmaceuticals to ensure patient safety. Towa Pharmaceutical, the manufacturer of Duloxetine Pensa Pharma, has been operating in the pharmaceutical market for over 70 years and specializes in producing generics. If any discrepancies are found, the company is required to immediately notify the regulator and arrange a product recall. Such measures help maintain a high level of trust in the country’s healthcare system.
