Impurities in valsartan products: risks currently being investigated


In Europe, a number of medicinal products containing the active substance valsartan produced by the Chinese manufacturer Zhejiang Huahai Pharmaceutical are being recalled. There is a risk that certain batches may have been contaminated with the carcinogenic substance N-nitrosodimethylamine during the production process.

Swissmedic, together with partner agencies and the authorisation holders concerned, are checking to see which batches in Switzerland are affected. To this end, Swissmedic is also conducting its own laboratory tests. The precautionary recall of potentially affected batches in Switzerland is planned for next week.

At the same time, investigations are underway to ascertain whether any other medicinal products are affected that contain chemically related active substances and were produced by the same Chinese manufacturer. As soon as any significant results are available, Swissmedic will issue updates on the situation through this communication channel.

Medicines containing the active substance valsartan are used to treat high blood pressure and heart failure.

Patients currently taking medicinal products that contain valsartan must on no account discontinue them without first consulting a doctor:

  • to stop taking these medicines without prior consultation would pose a far greater risk to health than the possible risk presented by the reported impurities
  • not all of the approved medicines containing the active substance valsartan originated from the manufacturer in question. Investigations are in progress to find out which products and batches were manufactured using active substances from Zhejiang Huahai Pharmaceutical.



Precautionary batch recalls

In consultation with the Swiss Agency for Therapeutic Products Swissmedic, the marketing authorisation holders concerned recall the following preparations and batches in Switzerland and the Principality of Liechtenstein up to the retail trade level.