More than 600,000 bottles of the blood pressure medication ramipril are being recalled across the United States after Lupin Pharmaceuticals identified a manufacturing compliance issue. The U.S. Food and Drug Administration confirmed the recall, which affects patients using ramipril to manage hypertension, heart failure, and post–heart attack recovery.
According to the FDA, 616,506 bottles were distributed nationwide before regulators discovered that the drug’s active pharmaceutical ingredient came from an unapproved supplier. While no contamination or adverse health effects have been reported, using an unapproved source violates federal manufacturing standards. The FDA has classified the action as a Class II recall, meaning potential health effects are considered temporary or medically reversible, with a low risk of serious harm.
The recall includes multiple strengths of ramipril, with the largest portion involving 10 mg doses. Health officials stress that patients should not stop taking the medication abruptly, as doing so could cause dangerous spikes in blood pressure. Instead, patients are urged to consult their doctors or pharmacists to confirm whether their prescription is affected and arrange a replacement if needed.
Lupin says the recall is voluntary and precautionary and that it is auditing its supply chain to prevent future issues.
