Valsatran, a drug used to control blood pressure and help prevent heart failure is being recalled in 22 countries including Malta, according to a report on CNN.
According to the European Medicines Agency, the recall is because the drug contains a chemical that poses a potential cancer risk.
The Health authorities in Malta said they are following the situation.
Valsartan is off-patent and is used as a component of other generic medicines.
Novartis, the company that originally developed the drug, said Sandoz valsartan and Valsartan/HCT film-coated tablets are being recalled since they "do not meet our high quality standards".
The recall involves about 2,300 batches that were sent to Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain and Malta, CNN said.
The problem was discovered during tests of batches of Valsartan's active pharmaceutical ingredient, as those from an external supplier contained an impurity.
The European Medicines Agency (EMA)reviewed medicines from the supplier, Zhejiang Huahai Pharmaceuticals in Linhai, China. The agency said the impurity is "a result of a change in the manufacturing process".
Novartis said its products Diovan / Co-Diovan / Exforge are not impacted by the recall. They remain on the market and there is absolutely nothing wrong with these Novartis brands.
EMA's information for patients
• An unexpected impurity has been found in the active ingredient used to make some valsartan medicines.
• Only some valsartan medicines in the EU are affected and these are being recalled.
• You should not stop taking your valsartan medicine unless you have been told to do so by your doctor or pharmacist.
• You may be given a different valsartan medicine (or an alternative treatment) when you go for your next prescription.
• If you have any questions about your treatment, speak to your pharmacist who can tell you if your medicine is being recalled.
• If you are in a clinical trial with valsartan and have any questions, speak to the doctor treating you in the trial.
• EMA will assess whether the impurity may pose any risk for patients. Further information will be provided once available.
Information for healthcare professionals
• N-nitrosodimethylamine (NDMA) has been detected in the valsartan active substance manufactured by Zhejiang Huahai Pharmaceuticals.
• As a result, valsartan medicines containing the active substance from Zhejiang Huahai are being recalled in the EU.