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 recalls 16 since 2013
Last 12 months 1 reported
Class I 0 0% of total
Ongoing 1 latest 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%
Why divalproex is recalled
Ongoing divalproex recalls 1 active
All divalproex recalls, newest first 16 total
Reported Class Recall Company Reason Where 29 Jul 2026 Drug CLASS II Divalproex Sodium Delayed-Release Tablets, USP, 500 mg recalled Divalproex Sodium Bionpharma Other Nationwide 3 Apr 2024 Drug CLASS II Divalproex Sodium Extended-release Tablets, USP 250 mg recalled Divalproex Sodium Amneal Pharmaceuticals of New York Potency & Assay Nationwide 31 Aug 2022 Drug CLASS II Divalproex Sodium Extended Release Tablets, USP, 250 mg recalled Divalproex Sodium Amneal Pharmaceuticals of New York Potency & Assay Nationwide 3 Aug 2022 Drug CLASS II Divalproex Sodium Delayed-Release Tablets, USP 500mg recalled Divalproex Sodium Sun Pharmaceutical Industries Potency & Assay Nationwide 7 Aug 2019 Drug CLASS II Divalproex Sodium Extended-release Tablets, USP Tablets recalled Divalproex Sodium Major Pharmaceuticals Manufacturing (CGMP) Deviations Nationwide 24 Apr 2019 Drug CLASS II Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) bottle recalled Dr. Reddy's Laboratories Manufacturing (CGMP) Deviations Nationwide 27 Feb 2019 Drug CLASS II Divalproex Sodium Extended-release Tablets, USP 250 mg recalled Divalproex Sodium Dr. Reddy's Laboratories Potency & Assay Nationwide 24 Jan 2018 Drug CLASS II Divalproex Sodium Delayed Release Tablets USP, 500 mg recalled Divalproex Sodium Unichem Pharmaceuticals Usa Other Nationwide 9 Aug 2017 Drug CLASS II Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) bottle recalled Zydus Pharmaceuticals USA Potency & Assay Nationwide 9 Aug 2017 Drug CLASS II Divalproex Sodium Delayed Release Tablets, USP, 125 mg recalled Zydus Pharmaceuticals USA Potency & Assay Nationwide
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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.