US Drug Recall Register
Class II · Moderate risk Terminated Initiated Apr 24, 2019 (7 years ago)

DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose…

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 Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.

Recalling firm
Major Pharmaceuticals
NDC code
0904-6363-61
Origin
MI, United States
Initiated by
N/A
FDA recall number
D-1583-2019

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.

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