Indian drugmaker Granules has issued a voluntary recall of more than 33,000 bottles of the generic high blood pressure treatment metoprolol succinate, citing the drug's failure to meet dissolution standards during routine stability testing.
The recall, detailed in the FDA's weekly enforcement report, covers extended-release tablets of metoprolol succinate in 100-count and 500-count bottles. The suspect batches were produced at one of Granule's manufacturing facilities in India for its U.S. subsidiary, according to the FDA posting.
The company issued the recall on June 24. Both lots involved in the product pull carried an expiration date of Dec. 31, 2025, and were distributed throughout the U.S.
“Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month long-term,” the recall notice states.
The action has been classified as a Class II recall, which means Granules' drug is unlikely to cause serious injury or death but could lead to temporary health problems for patients if used. The FDA's enforcement report did not specify if the company had received any reports of adverse effects related to the recalled drug.
The recall comes several months after the FDA slapped Granules with a warning letter that chastised the company over multiple production shortfalls at its manufacturing facility in Telangana, India. The problems outlined by the FDA included subpar cleaning, building maintenance, equipment upkeep and more.
That rebuke landed shortly after Granules announced that it would shell out $22.3 million to buy Swiss peptide specialist Senn Chemicals in late February. Granules charted the deal in a bid to break into the contract manufacturing industry, with a specific focus on peptide-based drugs like GLP-1s for diabetes and obesity.