Skip to main content

Divalproex Sodium

FDA recalls

8 rows

DateCompany and reasonClass
Jun 25, 2026Bionpharma Inc.
Presence of Foreign Tablets/Capsules		Class II · Ongoing
Dec 25, 2023Amneal Pharmaceuticals of New York, LLC
Failed dissolution specifications		Class II · Terminated
Jul 26, 2022Amneal Pharmaceuticals of New York, LLC
Failed dissolution specifications.		Class II · Terminated
Jun 26, 2022Sun Pharmaceutical Industries Inc
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.		Class II · Terminated
Apr 23, 2019Major Pharmaceuticals
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.		Class II · Terminated
Jan 30, 2019Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications: Out of specification results observed for high dissolution.		Class II · Terminated
Dec 18, 2017Unichem Pharmaceuticals Usa Inc
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.		Class II · Terminated
May 21, 2015Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications; exceeded specification at the 9 hour time point		Class II · Terminated

← Back to Divalproex Sodium

Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).