Reported Feb 27, 2019 · Terminated

Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories…

Dr. Reddy's Laboratories, 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: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623

Is this the product you have?

  • Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd
  • ByDr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01
Lot codes and dates
    • Lot #: C802676
    • Exp 03/20
Amount recalled
10,656 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications: Out of specification results observed for high dissolution.

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 Feb 14, 2023 · Data as of Sep 19, 7:19 PM UTC

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