Has Benicar been recalled? No. However, in July 2013, the FDA required the addition of warnings regarding the risk of sprue-like enteropathy and villous atrophy to the drug labels of Benicar, Benicar HCT, Tribenzor and Azor.

Has Benicar been taken off the market?

Benicar has not been taken off the market. People filed the first federal Benicar lawsuits in 2014 after the Food and Drug Administration warned that drugs containing olmesartan could cause sprue-like enteropathy, a disease known to cause severe diarrhea and weight loss.

Is Benicar safe now?

FDA has not concluded that Benicar increases the risk of death. The Agency is reviewing this safety concern and will update the public when additional information is available. FDA believes the benefits of Benicar in patients with high blood pressure continue to outweigh the potential risks.