FDA Recalls of Generic Versions of ARBs: An Update

Ongoing recalls of generic versions of angiotensin-receptor blockers (ARBs) have rattled patients and providers alike. The recalls began in July 2018 when a nitrosamine, the probable carcinogen N-nitrosodimethylamine (NDMA), was detected in certain manufacturing lots of generic valsartan. Shortly thereafter, a second probable carcinogen, the nitrosamine N-nitrosodiethylamine (NDEA), was identified. Over the ensuing months, the FDA recalled not only specific lots of valsartan-containing products but also particular lots of irbesartan- and losartan-containing products. In the fall, a third nitrosamine, N-nitroso-N-methyl-4-aminobutyric acid (NMBA), was detected as well. Originally, Zhejiang Huahai Pharmaceuticals in China was found to be the …