Glenmark Recalls Over 110000 Bottles of BP and COPD Drugs in US Due to Safety Concerns

Glenmark Pharmaceuticals has announced a voluntary recall in the US, pulling more than 88,000 bottles of Carvedilol (a high blood pressure drug) and 22,656 bottles of Theophylline (used for COPD) from the market. The affected products were manufactured at Glenmark’s Goa and Pithampur plants in India.

The US FDA flagged five Carvedilol lots after detecting N-Nitroso Carvedilol Impurity-1 (NNCI) levels above the permissible 4.0 ppm limit, and one Theophylline lot due to failure in dissolution tests. Both issues prompted Class II recalls, suggesting the risk of serious harm is remote but temporary or reversible side effects are possible.

Carvedilol is a beta-blocker for treating hypertension, while Theophylline helps manage asthma and COPD by relaxing airway muscles. Glenmark initiated the recalls earlier this month, emphasizing patient safety and regulatory compliance.