Certain Valsartan Products Produced by Torrent Pharmaceuticals Limited Recalled

The Food and Drug Administration (FDA) is alerting healthcare professionals and patients that Torrent Pharmaceuticals Limited is voluntarily recalling 16 lots of valsartan/amlodipine tablets and valsartan/ amlodipine/hydrochlorothiazide (HCTZ) tablets.

The reason for this recall notice is because the FDA recently learned Torrent used affected valsartan active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals, China.

Previously, on July 13th, the FDA announced the recall of non-expired products that contain the ingredient valsartan, supplied by Zhejiang Huahai.

The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes.

NDMA has been classified as a probable human carcinogen, as per International Agency for Research on Cancer (IARC) classification. 

However, not all Torrent valsartan products distributed in the USA are affected by this recall since all valsartan products do not contain N-Nitrosodimethylamine.

To date, Torrent has not received any reports of adverse events related to this recall.

Additionally, the 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 Pharmaceuticals ’s valsartan products and today’s Torrent’s recall.

Camber’s valsartan-containing products are produced by Hetero Labs. 

More than 20 European countries, Canada, and the United States have recalled valsartan medications in recent weeks.

The FDA is reminding patients taking valsartan from a recalled lot that they should continue taking their current medicine until their doctor or pharmacist provides a replacement or a different treatment option.

This means pharmacists may be able to provide a refill of valsartan medication not affected by the recall, or doctors may prescribe a different medication that treats the same condition.

Consumers and health care professionals should report any adverse reactions with valsartan-containing products, to the FDA’s MedWatch program to help the agency better understand the scope of the problem.