Indian pharmaceutical company Lupin has initiated a voluntary recall of more than 600,000 bottles of the blood pressure and heart failure medication ramipril. The decision comes after discovering the use of an active pharmaceutical ingredient (API) from an unapproved vendor.
The U.S. Food and Drug Administration (FDA) classified the recall as Class II, meaning the product is unlikely to cause severe health risks or death. The affected ramipril bottles were manufactured at Lupin’s facility in Goa, India.
Nationwide Recall Affects Hundreds of Thousands of Bottles
The recall, announced on October 23, with a Center Classification Date: 11/19/2024 involves 616,506 bottles of ramipril. Distributed by 30 wholesalers across the United States, the medication is commonly prescribed to manage high blood pressure (hypertension), treat heart failure, and aid recovery after heart attacks.
This recall follows another high-profile case involving Indian pharmaceutical companies. Just weeks ago, the U.S. unit of Dr. Reddy’s Laboratories recalled 331,590 bottles of cinacalcet tablets, used to treat hyperparathyroidism, due to the detection of a known carcinogen. Similar to Lupin’s recall, these products were distributed nationwide.
If you know anyone relying these drugs, please let them know.