The company said that the likelihood of someone getting sick "is expected to be rare, but the remote risk of infection to a patient cannot be ruled out." Mylan added that as of Friday's announcement, there had been no reports of adverse events related to the party in question.
Mylan refused to provide further information about the product or the foreign drug.
The voluntary recall includes a single bottle, each containing 500 0.5 milligram tablets, distributed in the United States between July and August. The number affected was 8082708, and the expiry date is listed as September 2020.