US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 22, 2015 (11 years ago)

Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100…

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

Why it was recalled

Failed Dissolution Specifications; exceeded specification at the 9 hour time point

What was recalled

Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India

Recalling firm
Dr. Reddy's Laboratories, Inc.
NDC code
55111-533-01
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1135-2015

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.

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