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Class II · ModerateRecall completed

Divalproex Sodium

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: AR210705, Exp 04/2024
Where it was soldUSA nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed dissolution specifications.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAmneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ foreign manufacturer
Brand nameDIVALPROEX SODIUM
Generic nameDIVALPROEX SODIUM
Active ingredient(s)DIVALPROEX SODIUM
Distributed by / forAmneal Pharmaceuticals, Bridgewater, NJ
NDC65162-755-10
Show the full FDA record
Full product labelDivalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10
Recalling firmAmneal Pharmaceuticals of New York, LLC
DistributionUSA nationwide
Quantity4,309 bottles
Recall initiated2022-07-27
Report date2022-08-31
Recall completed2023-08-17
Recall numberD-1362-2022
ClassificationClass II
FDA statusTerminated
Origin on fileBrookhaven NY United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.