What Happened to Valsartan?

Valsartan, an angiotensin II receptor blocker (ARB) medication, was initially patented by Novartis Pharmaceuticals in 1996 under the brand name Diovan, used to treat hypertension, heart failure, and post-myocardial infarction conditions. Its generic versions became widely available after the patent expired in 2012, leading to increased outsourcing of Active Pharmaceutical Ingredient (API) manufacturing, often to facilities in China and India.

The crisis began in July 2018 when the European Medicines Agency (EMA) and subsequently the U.S. Food and Drug Administration (FDA) announced recalls of valsartan-containing medicines. The reason was the discovery of N-nitrosodimethylamine (NDMA), a probable human carcinogen, in valsartan API manufactured by Zhejiang Huahai Pharmaceutical Co Ltd (ZHP) in China. Investigations revealed that changes in ZHP's manufacturing process in 2012, particularly the solvent system used, promoted the formation of NDMA. The FDA later found other impurities, N-nitrosodiethylamine (NDEA) and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), also classified as probable or potential human carcinogens, in valsartan and other ARBs like losartan and irbesartan from various manufacturers, including Hetero Labs, Aurobindo, Mylan, and Teva.

The consequences were extensive, leading to global recalls of hundreds of valsartan lots between 2018 and 2021, impacting millions of patients. The FDA estimated that the impurities might have been present in products for up to four years, with some recalled pills containing NDMA levels 3 to 177 times higher than the acceptable daily limit. This widespread contamination caused drug shortages and, in some cases, price hikes for unaffected versions of the medication.

In response, a federal multidistrict litigation (MDL No. 2875) was centralized in the District of New Jersey in February 2019, consolidating over 1,400 federal lawsuits against manufacturers and distributors. Plaintiffs allege negligence, failure to warn, and that companies prioritized profits over patient safety. As of March 2026, there were 1,418 pending lawsuits in the federal Valsartan litigation, growing to 1,426 by October 2026. The litigation involves personal injury claims (alleging various cancers like liver, bladder, colorectal, and stomach cancer) and economic loss claims.

Recent developments in 2026 include preliminary approval in February and final court approval in July for economic-loss settlements totaling over $15.2 million against Hetero, Aurobindo, and Vivimed for valsartan, irbesartan, and losartan claims. However, these settlements exclude personal injury and medical monitoring claims. The first bellwether trial for personal injury claims, scheduled for September 2025, was dismissed before reaching a jury in July 2026 due to the exclusion of the plaintiff's expert testimony under the Daubert standard, finding it scientifically unreliable. Wave 2 bellwether trials are anticipated for mid-2026. Separately, in August 2026, Novartis Pharmaceuticals initiated a Class II recall for a specific lot of Diovan (valsartan) tablets due to failed dissolution specifications, a quality issue distinct from the earlier carcinogen contamination. As of late September 2026, Valsartan still faces availability issues in some European countries, attributed to manufacturing problems and unexpectedly high demand.