These medications may contain traces of an antipsychotic. Nothing to do with their instructions.
The National Medicines Agency announced a drug recall for an unusual cause on March 25. In a press release, the ANSM informs of the recall of a batch of medicines which may contain traces of another medicinal substance, unrelated to its indications. One is for cardiovascular disorders, the other for psychiatric illnesses. “Pharmacists are asked to contact, by all means at their disposal, patients who have received one or more boxes from the batch concerned and to replace it (or them) with a box from another batch” warns the authority.
The recalled treatment is particularly taken by older people, after 65 years, with a history of cardiovascular disease or after an operation. This is a fragile population, under long-term treatment. This is not the first drug recall concerning this target in recent months: a drug for the heart as well as another for cholesterol were also recalled. In its new alert, the ANSM warns that “no adverse effects have been reported to date in connection with this quality defect” but “as a precautionary measure, we have asked the laboratory to recall all the boxes from the batch concerned”.
This laboratory is Viatris Santé. It was he who informed the ANSM of a quality defect in its generic drug Rivaroxaban Viatris 20 mg, tablet. This is an anticoagulant prescribed to prevent clots from forming in the blood. It is mainly used in patients suffering from atrial fibrillation to reduce the risk of stroke, but also in those who have already had phlebitis or pulmonary embolism to treat the clot and prevent recurrence. It can also be given after certain operations, particularly on the hip or knee, where the risk of thrombosis is high.
According to the manufacturer, one batch of Rivaroxaban Viatris 20 mg was “contaminated in very small quantities by another medicine during its manufacture”. This other medication is quetiapine. It is used in the treatment of certain psychiatric disorders such as schizophrenia and bipolarity, therefore nothing to do with the indications for the anticoagulant. “Investigations confirmed that quetiapine was present in very small quantities, a dose less than 0.05 mg per tablet. As a guide, therapeutic doses of quetiapine in adults are 50 to 600 mg per day” specifies the health agency.
The contaminated batch of Rivaroxaban Viatris 20 mg was distributed in pharmacies between January 27, 2026 and March 25, 2026. To recognize it, patients must look at their box: if the batch number 8212020 with the expiry date of 07/2028 appears there, the medicine is contaminated. According to Le Quotidien du Pharmacien, 95,160 boxes would be affected. Do not stop the treatment but return the box to the pharmacy as quickly as possible for an exchange. In the event of an adverse effect (drowsiness, migraine, dizziness, dry mouth), consult a doctor promptly. “There is no known interaction between rivaroxaban and quetiapine and to date”finally reassures the ANSM.
