Over 600,000 Bottles of Blood Pressure Medication Recalled in the U.S.

In a significant move affecting patients across the United States, Lupin Pharmaceuticals has voluntarily recalled more than 600,000 bottles of the blood pressure medication ramipril. The recall, which was confirmed by the U.S. Food and Drug Administration (FDA), involves 616,506 bottles distributed nationwide.

The decision was triggered after it was discovered that the active pharmaceutical ingredient (API) used to manufacture the medication came from an unapproved supplier. Although no immediate safety incidents have been reported, regulators classified the recall as a Class II event, meaning there is a low risk of serious harm but the possibility of temporary or reversible health effects exists.

The recall spans multiple dosages of ramipril, a widely prescribed medication used to treat hypertension and heart failure. Specifically, it includes about 110,000 bottles of the 2.5 mg strength, nearly 146,000 bottles of the 5 mg strength, and more than 350,000 bottles of the 10 mg strength. Patients who take the drug are being urged to check their medication bottles and consult with their pharmacists or healthcare providers if they are uncertain about whether their supply is part of the recall.

Lupin, one of India’s largest pharmaceutical manufacturers, has emphasized that the recall was voluntary and precautionary. The company stated that it is working closely with U.S. regulators to ensure the integrity of its supply chain and to prevent future incidents of this nature.

Healthcare experts stress that while the recall may cause concern, patients should not abruptly stop taking their prescribed medication without medical guidance, as untreated high blood pressure can pose serious risks. Instead, affected individuals are advised to seek alternatives or replacements through their doctors.

This recall serves as a reminder of the importance of strict quality control in pharmaceuticals and the critical role of regulatory oversight in protecting patient safety.