Divalproex Sodium Tablet, Delayed Release
FDA Recall NDC 69452-433
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Divalproex Sodium (NDC 69452-433). A significant event, classified as Class II, was initiated on Jun 26, 2026 by Bionpharma Inc.. The reported reason for this action was: "Presence of Foreign Tablets/Capsules"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of Foreign Tablets/Capsules
Jun 26, 2026
Jul 29, 2026
N/A
Recall Profile & Regulatory Data
Event ID
99316
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Bionpharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30.
Batch or Lot Expiration Information
Lot# 704C003, Exp. 12/31/2028
Affected Packages Involved in this Recall
69452-433-13Product
69452-433-20Product
69452-433-30Product
69452-434-13Product
69452-434-20Product
69452-434-30Product
69452-435-13Product
69452-435-20Product
69452-435-30Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
