By Jack Phillips
A recall of more than 100,000 bottles of a commonly used beta-blocker drug used to treat high blood pressure was classified by the Food and Drug Administration at its second-highest recall level.
According to a notice issued by the FDA last week, 112,327 bottles of metoprolol succinate extended-release tablets manufactured by Teva Pharmaceuticals were recalled nationwide.
The FDA declared a Class II recall on Feb. 27, which the agency defines as 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 nationwide recall affects several doses of the drug, including 25-, 50-, 100-, and 200-milligram versions. Bottles with 100 tablets and 1,000 tablets are under recall.
According to the FDA, the reason was because of “failed dissolution specifications,” which federal officials have said occur when a drug may not break down efficiently in the body.
Teva Pharmaceuticals did not issue a press release for the recall, which was initiated on Jan. 29. The FDA said it is ongoing.
Drug database website ClinCalc says that metoprolol succinate was the sixth-most prescribed medication in the United States in 2023, with more than 14.8 million estimated patients and 59.5 million prescriptions filled out that year.
The drug is classified as a beta-blocker, which are medications generally used to treat heart-related conditions, and can be prescribed for high blood pressure, heart failure, and angina, a symptom of coronary heart disease. Metoprolol succinate is sometimes sold under the brand name Toprol-XL.
“Metoprolol is also used to treat severe chest pain (angina) and lowers the risk of repeated heart attacks,” the Mayo Clinic website states.
“It is given to people who have already had a heart attack. In addition, metoprolol is used to treat patients with heart failure.”
4 Strengths Under Recall
The FDA notice listed four metoprolol strengths under recall:
- Metoprolol Succinate ER; 200 mg; with lot numbers: 0686H251, 0687H251, 10688H251
- Metoprolol Succinate ER; 100 mg; with lot numbers: 0718J251, 0729J251, 0730J251, 0718J252, 0729J252, 0730J252
- Metoprolol Succinate ER; 50 mg; with lot numbers: 0486G251, 0487G251, 0488G251, 0486G252, 0487G253, 0488G252
- Metoprolol Succinate ER; 25 mg; with lot numbers: 0715J251, 0716J251, 0717J251, 0715J252, 0716J252, 0717J252
A list of lot numbers and code information about the recalled products can be found via the FDA website.
Last year, the FDA announced a separate recall of more than 33,000 bottles of metoprolol succinate manufactured by India-based Granules Pharmaceuticals Inc. across the United States. The recall was initiated because the “product failed to meet dissolution acceptance criteria,” the FDA said.
