Reported Apr 3, 2024 · Terminated

Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals…

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, Rx Only, 100 tablets
  • Manufactured byAmneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA
  • Distributed byAmneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10
Lot codes and dates
    • Lot # AR210704
    • exp. date 04/2024 AR210706
    • exp. date 04/2024 AR210707
    • exp. date 04/2024 AR210708
    • exp. date 04/2024 AR210709
    • exp. date 04/2024
Amount recalled
21,452/100 count 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 16, 2024 · Data as of Sep 19, 2:53 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.