Reported Apr 24, 2019 · Terminated

Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle…

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 a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd
  • ByDr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA
Lot codes and dates
    • Lot #: a) C802629
    • Exp. 03/2020
    • C805680
    • Exp. 07/2020
    • C808821
    • Exp. 10/2020
    • b) C806561
    • Exp. 10/2020
Amount recalled
33,958 bottles

Why it was recalled

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

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Dr. Reddy's Laboratories, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 25, 2020 · Data as of Sep 19, 7:22 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.