Divalproex recalls

The FDA has published 16 recalls involving Divalproex since 2013. The latest was reported on 29 Jul 2026. Most were for potency & assay. Dr. Reddy's Laboratories has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls16since 2013
Last 12 months1reported
Class I00% of total
Ongoing1latest 29 Jul 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 14 88%Class III 2 13%

By year

Ongoing divalproex recalls

1 active
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIDivalproex Sodium Delayed-Release Tablets, USP, 500 mg recalledDivalproex SodiumBionpharmaOtherNationwide

All divalproex recalls, newest first

16 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIDivalproex Sodium Delayed-Release Tablets, USP, 500 mg recalledDivalproex SodiumBionpharmaOtherNationwide
DrugCLASS IIDivalproex Sodium Extended-release Tablets, USP 250 mg recalledDivalproex SodiumAmneal Pharmaceuticals of New YorkPotency & AssayNationwide
DrugCLASS IIDivalproex Sodium Extended Release Tablets, USP, 250 mg recalledDivalproex SodiumAmneal Pharmaceuticals of New YorkPotency & AssayNationwide
DrugCLASS IIDivalproex Sodium Delayed-Release Tablets, USP 500mg recalledDivalproex SodiumSun Pharmaceutical IndustriesPotency & AssayNationwide
DrugCLASS IIDivalproex Sodium Extended-release Tablets, USP Tablets recalledDivalproex SodiumMajor PharmaceuticalsManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIDivalproex Sodium Extended-Release Tablets, USP, 250 mg a) bottle recalledDr. Reddy's LaboratoriesManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIDivalproex Sodium Extended-release Tablets, USP 250 mg recalledDivalproex SodiumDr. Reddy's LaboratoriesPotency & AssayNationwide
DrugCLASS IIDivalproex Sodium Delayed Release Tablets USP, 500 mg recalledDivalproex SodiumUnichem Pharmaceuticals UsaOtherNationwide
DrugCLASS IIDivalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) bottle recalledZydus Pharmaceuticals USAPotency & AssayNationwide
DrugCLASS IIDivalproex Sodium Delayed Release Tablets, USP, 125 mg recalledZydus Pharmaceuticals USAPotency & AssayNationwide

Should you stop taking Divalproex?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.