FDA Classifies Nationwide Recall of Blood Pressure Drug Ramipril Due to Impurity

The U.S. Food and Drug Administration (FDA) has classified a nationwide recall of over 28,000 bottles of the blood pressure medication ramipril as a Class II recall. The recall, voluntarily initiated by Hikma Pharmaceuticals USA Inc. on August 24, 2026, and classified by the FDA on September 3, 2026, is due to failed impurity and degradation specifications, specifically an out-of-specification result for dicyclohexylurea (DCU). The affected 10-milligram ramipril capsules were distributed in 100-capsule and 500-capsule bottles.