Divalproex Sodium Extended-Release Tablets Recalled

Dr. Reddy's Laboratories Inc. is recalling nearly 34,000 bottles of divalproex sodium extended-release tablets because the drug was exposed to high humidity during packaging, according to the April 24, 2019, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 100-count bottles (NDC 55111-0533-01) from lots C802629 (Exp. 3/20), C805680 (Exp. 7/20), and C808821 (Exp. 10/20). Also recalled are 500-count bottles (NDC 55111-0533-05) from lot C806561 (Exp. 10/20). The tablets were distributed to major distributors and retailers that may have further distributed the product throughout the United States. 

Dr. Reddy's Laboratories voluntarily issued the recall April 11, 2019. On April 15, 2019, the FDA designated it a Class II recall. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists. 

Divalproex sodium is a prescription anticonvulsant used to treat seizures, bipolar disorder, and migraine headaches. 

—Jolynn Tumolo