June 24, 2014 — The U.S. Food and Drug Administration (FDA) has announced a Class II recall for about 13,500 bottles of generic Toprol XL (metoprolol succinate) because they failed a dissolution test.
This is the second major recall for generic Toprol XL in the last two months. Another Indian drug-maker, Wockhardt, recalled over 109,000 bottles of the drug last month for the same problem.
Toprol XL is an anti-hypertensive drug. No injuries have been reported. The FDA believes any health problems would be temporary and unlikely to cause serious complications or death.
It appears that doctors have been warning about problems with generic Toprol XL since at least 2012. According to the New York Times, Dr. Harry Lever, a cardiologist at the Cleveland Clinic, noticed that his patients experienced chest pain or other symptoms when they switched from brand-name Toprol XL (manufactured by AstraZeneca) to generic metoprolol.
In 2009, generic Toprol XL was recalled by Sandoz and Ethex. Although the FDA insists that generic medicines are as safe and effective as brand-name drugs, a series of recalls have raised safety concerns. In March, Dr. Reddy’s recalled 60,000 bottles of lansoprazole, a heartburn drug, in the United States. The FDA recently banned Dr. Reddy’s from exporting drugs produced by two Indian facilities into the U.S. after inspections found serious quality-control issues.