A New Jersey-based drug company is recalling thousands of bottles of a high blood pressure and heart drug due to the presence of foreign tablets or capsules in the product, according to a notice published by the Food and Drug Administration (FDA) this week.
Advagen Pharma Limited is recalling 3,684 bottles of metoprolol tartrate tablets, USP, in 50-milligram doses, the notice said. Each bottle holds 1,000 tablets, it added.
The reason for the recall, it said, is because of the “presence of foreign tablets/capsules” in the product. The notice did not provide more details about the contamination.
The batch number for the recalled medication is 2611C065A1, and it has an expiration date of May 2028. The tablets were distributed around the United States.
The recall was initiated on Oct. 27, 2026, according to the notice, which said that customers were notified via letter. The FDA classified the recall as class II and included it in its weekly enforcement report on Nov. 11.
A class II recall is a “situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” the federal health regulator says on its website.
While the recall notice did not say what consumers should do with the product, the FDA says on another section of its website that for class II or III recalls, “consumers can generally continue taking the medicine unless the recalling company provides other instructions.” The company did not list any other instructions.
“In some instances, stopping your medicine may be more harmful to your health than continuing to take the recalled medicine,” the agency says. “Talk to your doctor or pharmacist if you have questions or concerns about your medicine. Additionally, companies may advise consumers to return recalled medications to their place of purchase.”
According to the Mayo Clinic and other health websites, metoprolol is used by itself or with other drugs to treat high blood pressure and severe chest pain known as angina. It is also used to lower the risk of repeated heart attacks.
Metoprolol, classified as a beta blocker, is one of the most commonly prescribed and used medications in the United States, according to the ClinCalc drug database. More than 58 million prescriptions were estimated to have been out for the drug in 2024, while nearly 14.6 million people take the medication.
Other drug companies have recalled lots of metoprolol earlier this year, including one lot of metoprolol succinate made by Alkem Laboratories Ltd. and multiple lots of metoprolol succinate made by Teva Pharmaceuticals.
