Reported Aug 3, 2022 · Terminated

Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical…

Sun Pharmaceutical Industries 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: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620

Is this the product you have?

  • Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets
  • Distributed bySun Pharmaceutical Industries, Inc., Cranbury, NJ 08512
  • Manufactured bySun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol- 389 350, Gujarat, India, NDC 62756-798-88
Lot codes and dates
  • Lot
    • HAC1312A
    • EXP. 05/2024
Amount recalled
9552 bottles

Where it was sold

  • Nationwide

Why it was recalled

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

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 May 31, 2023 · Data as of Sep 19, 5:54 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.