In July 2018, the FDA and at least 22 health and safety agencies in other countries, issued recalls for Valsartan due to the discovery of traces of a chemical known as N-nitrosodimethylamine (NDMA) in the drug. The FDA has stated that the contamination likely was caused by changes to the drug’s manufacturing process, and that some valsartan products may have contained NDMA for as long as four years.
Since the initial announcement, the valsartan recall has been expanded to include valsartan-containing products (including valsartan/hydrochlorothiazide) from these affected companies:
