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The U.S. Food and Drug Administration (FDA) has upgraded a nationwide recall of more than 33,000 bottles of the blood pressure medication metoprolol succinate extended-release to a Class II recall, its second-highest level of concern.

The recall, initiated by India-based Granules Pharmaceuticals Inc., affects 25 mg tablets in 100-count and 500-count bottles that expire on December 31, 2025. The FDA said the drug failed to meet dissolution standards during stability testing, meaning it might not release the active ingredient properly over time.

Although the recall is not expected to cause serious harm, the FDA warns that it could lead to temporary health issues in some patients. So far, no adverse events have been reported.

Granules Pharmaceuticals has not issued a public statement, but the recall follows an earlier FDA warning letter about contamination and maintenance issues at the company’s Telangana, India plant—where inspectors found inadequate cleaning, faulty filters, and even bird droppings in the facility’s air handling system. The company has since claimed to have corrected the violations.

Metoprolol, a beta-blocker commonly prescribed for high blood pressure, heart failure, and chest pain, was the sixth-most prescribed drug in the U.S. in 2022, with over 65 million prescriptions. The recall only affects the generic version—brand-name drugs like Lopressor and Toprol-XL are not included.

This comes shortly after another FDA recall of over 700,000 bottles of the beta-blocker carvedilol, due to the presence of a carcinogenic impurity