Controversies

NDMA impurity detected in valsartan API, triggering global recalls and import restrictions

In 2018, NDMA was detected in valsartan active pharmaceutical ingredient (API) produced by Zhejiang Huahai Pharmaceutical, prompting recalls of affected medicines in multiple countries; the timing of disclosure and recall in China drew scrutiny. The company halted production and described its risk assessment and communications with regulators; subsequent restrictions were placed by European and U.S. authorities on certain products linked to its Chuannan production site. The incident was confined to the affected API and that facility.