A pharmaceutical company is recalling thousands of bottles of a commonly used heart and blood pressure medication, according to a notice published by the Food and Drug Administration (FDA) this week.
The notice said that 17,304 100-count bottles of metoprolol succinate extended-release tablets, manufactured by India-based Alkem Laboratories Ltd. and distributed by New Jersey-based Ascend Laboratories, are under recall.
The tablets are in 25-milligram strength, while the medication has a lot number of 25140859 and an expiration date of January 2027, according to the notice.
The reason for the recall is a “dissolution failure,” referring to an FDA term that indicates a drug failed laboratory quality testing because the active ingredient was not absorbed properly in the body.
The recall is ongoing and nationwide, the notice said. Neither Alkem nor Ascend issued a press release for the action.
The FDA, which has not yet classified the recall, published the notice on its website this week. The recall was initiated by Ascend Laboratories on April 27.
Metoprolol is among the most commonly used and prescribed drugs in the country, with 59.5 million prescriptions being issued in 2023, according to the ClinCalc database. More than 14 million people were estimated to have taken the drug that year.
The drug, which is prescription-only, is sold under several brand names, including Lopressor and Toprol-XL. Metoprolol succinate extended-release is the generic form of Toprol-XL. No branded versions of metoprolol were included in this week's recall.
The Mayo Clinic says on its website that the drug is a beta-blocker that is used to treat high blood pressure, angina, and heart failure, as well as improving the survival rate following a heart attack. The drug works by slowing down the heart rate and lowering the force of heart contractions, it says.
In 2024, Alkem Labs was cited by the FDA in the wake of a March inspection at one of its facilities in India. The FDA said that during an inspection, officials found that the company did not review unexplained problems with its components or whether a failed batch of its products was distributed to its customers, among other issues.
Separately, the FDA published a notice last week that 675 bottles of 20-milligram enalapril maleate tablets in 1,000-count bottles are under recall. They were distributed by New Jersey-based Rising Pharma Holdings and manufactured by Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals in India.
The enalapril maleate tablets, used to treat high blood pressure, were recalled due to “failed impurities/degradation specifications,” namely because of an “out of specification result occurred in organic impurities test,” said the notice.
The product was recalled last month, and the FDA classified it as Class II on May 5. The classification means that there 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 agency says on its website.