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

Divalproex Sodium Delayed Release Tablets

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.

Other Divalproex recalls

See all
Class II · Moderate risk Terminated

Divalproex Sodium Delayed-Release Tablets

Reason Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.

Sun Pharmaceutical Industries INC NDC 62756-798-88 D-1291-2022
Class II · Moderate risk Terminated

Divalproex Sodium Extended-Release Tablets

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

Major Pharmaceuticals NDC 0904-6363-61 D-1583-2019