The FDA said that a generic version of metoprolol was recalled because it failed to meet the agency’s criteria.

The Food and Drug Administration on Tuesday
upgraded a recall of a generic version of blood pressure medication metoprolol to its second-highest level because it failed to meet the FDA’s own criteria.
The recall notice encompasses metoprolol succinate extended-release tablets in 25 milligram doses in 100-count and 500-count bottles. India-based Granules Pharmaceuticals Inc., the manufacturer, voluntarily recalled the medication, which is a beta-blocker used to treat high blood pressure, heart failure, and angina, or chest pain.
Both recalled lots, or roughly 33,000 bottles, have an expiration date of Dec. 31, 2025. They were also distributed throughout the United States, according to the notice.
The FDA said the reason for the recall is that the “product failed to meet dissolution acceptance criteria in the stability studies at the 6th month.”
While the recall was issued on June 24, the FDA on Tuesday designated it as
a Class II recall, meaning that the drug is unlikely to cause serious injury or death but may lead to temporary health problems if used by patients. The report didn’t say whether there were any adverse effects connected to the recalled product or whether patients should continue to take the medication as directed.
Granules Pharmaceuticals has not issued a statement on the recall, and the FDA’s notice said that no news release was issued for the action. The Epoch Times contacted the company for comment.
Several months ago, the FDA sent a
warning letter to Granules about several alleged production violations at its manufacturing plant in Telangana, India. The letter accused the company of subpar cleaning, not good enough equipment upkeep, and a number of other issues.
“Our investigators observed significant contamination in multiple ducts … used in the preparation of finished drug products manufactured at your facility,” the FDA’s letter said, in part. “While filters were installed to prevent contamination, inadequate cleaning and maintenance processes rendered them ineffective.”
It added that elsewhere, “bird droppings and feathers were observed during the inspection” in the factory’s air handling unit, among other alleged violations.
“Your response is inadequate. Cross-contamination is not uniform, and testing of limited reserve samples alone cannot ensure products are contaminant-free,” the February letter further said. “Immediate remediation, effective cleaning protocols, and comprehensive testing are essential to resolve this serious [current good manufacturing practice] violation.”
Last month, The Hindu
reported that Granules indicated in a regulatory filing that it had resolved the issues that were flagged by the FDA in its letter. The company “addressed and resolved the observation during the inspection,” it said in a filing.
In 2022, metoprolol was the sixth-most commonly prescribed medication in the United States,
according to ClinCalc, a database for pharmaceuticals. The estimated number of prescriptions stood at more than 65 million, with more than 15 million patients, for 2022.
The Cleveland Clinic
says that metoprolol is also the most commonly prescribed beta-blocker.
The recall also comes weeks after more than 700,000 bottles of the high blood pressure drug carvedilol were
recalled across the United States due to the presence of a carcinogenic substance, the FDA said. Like metoprolol, carvedilol is also a beta-blocker that’s used to treat high blood pressure and heart failure.