US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 10, 2017 (9 years ago)

Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC…

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

Why it was recalled

Failed Dissolution Specifications

What was recalled

Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054

Recalling firm
Zydus Pharmaceuticals USA Inc
NDC code
68382-032-01
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1042-2017

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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