Reported Aug 31, 2022 · Terminated

Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal…

Amneal Pharmaceuticals of New York, LLC

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: Amneal Pharmaceuticals of New York, LLC · 50 Horseblock Rd · Brookhaven, NY · 11719-9509

Is this the product you have?

  • Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only
  • Manufactured byAmneal Pharmaceuticals, India
  • Distributed byAmneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10
Lot codes and dates
    • Lot #: AR210705
    • Exp 04/2024
Amount recalled
4,309 bottles

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 Aug 17, 2023 · Data as of Sep 19, 8:07 PM UTC

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