FDA Updates on Angiotensin II Receptor Blocker (ARB) Recalls

FDA alerts patients and health care professionals to Teva’s recall of valsartan products due to NDEA
Update [11/27/2018] FDA is alerting patients and health care professionals to Teva Pharmaceuticals’ voluntary recall of valsartan-containing products manufactured using active pharmaceutical ingredient (API) from Mylan Pharmaceuticals. Mylan voluntarily recalled valsartan-containing products on November 20.
Teva is recalling all lots of amlodipine and valsartan combination tablets and amlodipine, valsartan, and hydrochlorothiazide (HCTZ) combination tablets due to the presence of N-Nitrosodiethylamine (NDEA). Teva has recalled other valsartan-containing products in recent months due to the presence of N-Nitrosodimethylamine (NDMA). With this recall, Teva has now recalled all their unexpired valsartan-containing products from the U.S. market.
The agency continues to investigate and test all angiotensin II receptor blocker (ARBs) for the presence of NDMA and NDEA and is taking swift action when it identifies these impurities that are above acceptable levels.
FDA has updated the list of valsartan products under recall and the list of valsartan products not under recall. The agency reminds patients taking this medication or any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option. It also is important to know that not all ARBs contain NDMA or NDEA, so pharmacists may be able to provide a refill of medication not affected by the recall, or doctors may prescribe a different medication that treats the same condition.