FDA updates recalled valsartan-containing product information

FDA is alerting health care professionals and patients that Torrent Pharmaceuticals Limited is voluntarily recalling 16 lots of valsartan/amlodipine tablets and valsartan/amlodipine/hydrochlorothiazide (HCTZ) tablets. Not all Torrent valsartan products distributed in the United States are being recalled.

FDA is alerting health care professionals and patients that Torrent Pharmaceuticals Limited is voluntarily recalling 16 lots of valsartan/amlodipine tablets and valsartan/amlodipine/hydrochlorothiazide (HCTZ) tablets. Not all Torrent valsartan products distributed in the United States are being recalled. FDA recently learned Torrent used affected valsartan active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. FDA testing confirmed NDMA in some Torrent products. To date, Torrent has not received any reports of adverse events related to this recall. FDA has updated the list of valsartan products under recall and the list of valsartan products not under recall to incorporate additional repackagers of Camber’s valsartan products and Torrent’s recall.