US Drug Recall Register
Class II · Moderate risk Terminated Initiated Apr 11, 2019 (7 years ago)

Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.

What was recalled

Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA

Recalling firm
Dr. Reddy's Laboratories, Inc.
NDC code
55111-0533-01
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1133-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Divalproex recalls

See all