Granules Pharmaceuticals, Inc.

Granules India Recalls 33,000 Bottles of Blood Pressure Medication in US Due to Manufacturing Defects

- Granules India is recalling over 33,000 bottles of Metoprolol Succinate extended-release tablets from the US market due to failed dissolution specifications during stability studies. - The US FDA classified this as a Class II recall, indicating potential for temporary or medically reversible health consequences with minimal likelihood of serious adverse outcomes. - This recall represents the latest in a series of quality control issues affecting Indian pharmaceutical manufacturers in the US market. - The affected medication failed to meet dissolution acceptance criteria at the sixth month of stability testing, prompting the nationwide recall initiated on June 24.