February 28, 2019
Dr. Reddy's Laboratories is recalling 10,656 bottles of divalproex sodium extended-release tablets, 250 mg, in 100-count bottles (NDC 55111-533-01) because dissolution results obtained during testing were too high, according to the February 27, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects bottles from lot C802676 (Exp. 3/20), which were distributed throughout the United States.
Dr. Reddy's Laboratories voluntarily initiated the recall January 31, 2019. On February 15, 2019, the FDA designated the recall Class II, communicating use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
Divalproex sodium is a prescription anticonvulsant medication used to treat seizure disorders as well as bipolar disorder, and to prevent migraine headaches.