US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 15, 2017 (9 years ago)

Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01)…

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

Why it was recalled

Failed Dissolution Specifications; 9 month long term stability

What was recalled

Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ

Recalling firm
Zydus Pharmaceuticals USA Inc
NDC code
68382-033-01
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0617-2017

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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