In July of 2018, the U.S. Food and Drug Administration (FDA) announced a series of voluntary recalls for several lots of valsartan-containing products due to contamination with the possible carcinogen N-nitrosodimethylamine (NDMA). The list of recalled products has continued to grow as more companies producing angiotensin II receptor blockers (ARBs) in the same class as valsartan, including products containing losartan and irbesartan, have discovered lots of drugs contaminated with NDMA or N-nitrosodiethylamine (NDEA).

Patients prescribed the affected products should not spontaneously discontinue treatment with these medications, as the risk of harm to the patients' health may be higher if the treatment is stopped immediately without any alternative treatment.

While the FDA's investigation is ongoing, the ACC is actively working to keep members up-to-date on the latest information. Click the following links to review updated lists of irbesartan products under recall, losartan medications under recall, valsartan products under recall and valsartan products not under recall.

In a 2018 Cardiology magazine perspective, Randall M. Zusman, MD, FACC, director of the division of hypertension at the Massachusetts General Hospital Heart Center, mapped his institution's response to the ever-expanding list of recalled drugs within this class and areas of improvement for the future identification of contaminated products. Read the full perspective here.

Updates:

Torrent Further Expands Voluntary Recall of Losartan (1/23/2019)
Torrent Pharmaceuticals is further expanding its voluntary recall to include six additional lots of losartan potassium and hydrochlorothiazide combination tablets, for a total of 16 lots of losartan-containing medicines. This recall is due to unacceptable amounts of NDEA in the losartan active pharmaceutical ingredient manufactured by Hetero Labs Limited.

Torrent is only recalling lots of losartan-containing medication containing NDEA above the interim acceptable intake limits of 0.27 parts per million.

Aurobindo Pharma, Torrent Pharmaceuticals Adds to ARB Recalls (1/3/2019)
Aurobindo Pharma USA, Inc. and Torrent Pharmaceuticals Limited announced voluntary recalls for select lots of valsartan tablets and losartan tablets, respectively, due to contamination with the possible carcinogen NDEA. These announcements are added to a growing list of recalls for potentially contaminated ARBs.

FDA Presents Interim Limits of Nitrosamines in Currently Marketed ARBs (12/19/2018)
The FDA is publishing interim acceptable intake levels of nitrosamine impurities in ARBs for manufacturers to use to ensure their finished drug products are safe for patients. The agency evaluated safety data for the probable human carcinogens N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) to determine an interim acceptable intake level for these impurities in the ARB class. See the full valsartan products under recall and irbesartan products under recall.

FDA Updates Recalls For Valsartan, Losartan and Irbesartan (12/4/2018)
The FDA expanded the Mylan voluntary recall to all lots of non-expired valsartan-containing products, including 104 additional lots containing amlodipine and valsartan tablets, valsartan tablets and valsartan and hydrochlorothiazide.

FDA Alerts Patients, Health Care Professionals to Teva's Recall of Valsartan Products (11/27/2018)
The FDA is alerting patients and health care professionals to Teva Pharmaceuticals' voluntary recall of valsartan-containing products manufactured using active pharmaceutical ingredient from Mylan Pharmaceuticals. Mylan voluntarily recalled valsartan-containing products on November 20. Review an updated list of valsartan products under recall and list of valsartan products not under recall. 

Sandoz Recalls Lot of Losartan Potassium and Hydrochlorothiazide Due to Contamination (11/8/2018)
The FDA is alerting patients and health care professionals to Sandoz's voluntary recall of one lot – JB8912 – of losartan potassium and hydrochlorothiazide 100mg/25mg tablets, that contain losartan, an ARB, and hydrochlorothiazide, a diuretic, used in combination for the treatment of hypertension. Sandoz's product was made using an active pharmaceutical ingredient that has tested positive for NDEA. The API was manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd, which is on import alert.

FDA Recalls Another Heart Medication Due to Contamination with Probable Carcinogen (11/1/2018)
On Oct. 30, the FDA announced a voluntary recall by ScieGen Pharmaceuticals, Inc. for several lots of irbesartan in USP 75 mg, 150 mg and 300 mg tablets due to the presence of NDEA. The irbesartan tablets (USP 75 mg, 150 mg and 300 mg) subject to recall are labeled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc. and are packed in 30-count and 90-count bottles. Review a list of the recalled lot numbers here. Read more on ACC.org.

FDA Places Zhejiang Huahai Pharmaceuticals on Import Alert (9/28/2018)
The FDA placed Zhejiang Huahai Pharmaceuticals on import alert on Sept. 28, 2018, to protect U.S. patients while the active pharmaceutical ingredient manufacturer fully determines how impurities were introduced into its API and remediates its quality systems. The import alert stops all API made by ZHP and finished drug products made using ZHP's API from legally entering the United States. FDA's action follows a recent inspection at ZHP's facility.

FDA Updates Recalled Valsartan-Containing Product Information (8/9/2018)
The FDA has updated the list of valsartan products under recall and the list of valsartan products not under recall to incorporate recalls of valsartan-containing products manufactured by Hetero Labs Limited, in India, labeled as Camber Pharmaceuticals Inc. Not all Camber valsartan products distributed in the U.S. are being recalled.

FDA Issues Recall For Several Medications Containing Valsartan (7/13/2018)
On July 13, the FDA announced the voluntary recall of several drugs containing the active ingredient valsartan, used to treat high blood pressure and heart failure, due to contamination with NDMA, a probable human carcinogen. The FDA is actively investigating NDMA levels in the recalled products and assessing effects on patients who have been taking the drugs. Patients taking the recalled products should continue taking the medicines as prescribed until they have a replacement product. Read more on ACC.org.

Keywords: ACC Advocacy, Losartan, Diethylnitrosamine, Dimethylnitrosamine, Angiotensin Receptor Antagonists, Carcinogens, United States Food and Drug Administration, Drug Recalls, Hypertension, Heart Failure

< Back to Listings