FDA Recalls Dr. Reddy’s Generic Toprol XL (Metoprolol)

June 24, 2014 — Indian drug-maker Dr. Reddy’s Laboratories are recalling 13,560 bottles of generic Toprol XL (metoprolol succinate) because the high blood-pressure drug does not dissolve as quickly as its brand-name counterpart.

In the last two months, Wockhardt and Dr. Reddy’s Laboratories have recalled more than 120,000 bottles because the generic drug was not dissolving properly. No injuries have been reported.

The New York Times reports that Dr. Harry Lever, a cardiologist at the Cleveland Clinic, has been warning about serious side effects from generic version of Toprol XL. He says several patients complained of chest pains or other symptoms after switching from brand-name Toprol XL, manufactured by AstraZeneca, to a generic drug manufactured in India. He reported his concerns to the FDA in 2012.

Federal regulators banned Wockhardt from exporting medicines into the United States over concerns about quality control issues at two Indian drug-making facilities. Generic Toprol XL has also been recalled by Sandoz and Ethex in 2009. Although the FDA insists that generic medicines are as safe and effective as brand-name counterparts, the recalls are concerning.

In March, Dr. Reddy’s recalled nearly 60,000 bottles of a heartburn drug lansoprazole in the U.S. over concern about bacterial contamination. The recalls are Class II, meaning that they could cause temporary health problems but are unlikely to cause severe injury or death.