Divalproex Sodium Tablet, Delayed Release
FDA Recall NDC 62756-796
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 62756-796). A significant event, classified as Class II, was initiated on Jun 27, 2022 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Jun 27, 2022
Aug 03, 2022
9552 bottles
Recall Profile & Regulatory Data
Event ID
90495
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
May 31, 2023
Product Description
Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol- 389 350, Gujarat, India, NDC 62756-798-88.
Batch or Lot Expiration Information
Lot# Lot: HAC1312A, EXP. 05/2024
Affected Packages Involved in this Recall
62756-796-83Product
62756-796-88Product
62756-796-08Product
62756-796-13Product
62756-796-18Product
62756-797-83Product
62756-797-88Product
62756-797-08Product
62756-797-13Product
62756-797-18Product
62756-798-83Product
62756-798-88Product
62756-798-08Product
62756-798-13Product
62756-798-18Product
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.
