Reported Aug 9, 2017 · Terminated

Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC…

Zydus Pharmaceuticals USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zydus Pharmaceuticals USA Inc · 73 Route 31 N · Pennington, NJ · 08534-3601

Is this the product you have?

  • 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 byZydus Pharmaceuticals, Pennington, NJ 07054
Lot codes and dates
  • 124 of 124 codes

    • MR5990
    • May-17
    • MR5991
    • May-17
    • MR7294
    • Jun-17
    • MR7295
    • Jun-17
    • MR7296
    • Jun-17
    • MR7297
    • Jun-17
    • MR7298
    • Jun-17
    • MR7603
    • Jun-17
    • MR7604
    • Jun-17
    • MR7605
    • Jun-17
    • MR7606
    • Jul-17
    • MR7607
    • Jul-17
    • MR8575
    • Aug-17
    • MR8576
    • Aug-17
    • MR8577
    • Aug-17
    • MR8882
    • Aug-17
    • MR8883
    • Aug-17
    • MR8884
    • Aug-17
    • MR8885
    • Aug-17
    • MR8886
    • Aug-17
    • MR9417
    • Aug-17
    • MR9418
    • Aug-17
    • MR9419
    • Aug-17
    • MR9499
    • Aug-17
    • MR9500
    • Aug-17
    • MR9501
    • Sep-17
    • MR9502
    • Sep-17
    • MR9601
    • Sep-17
    • MR9602
    • Sep-17
    • MR9805
    • Sep-17
Amount recalled
115,122 HDPE bottles

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 7, 2020 · Data as of Sep 19, 6:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.