Divalproex Sodium Tablet, Extended Release
FDA Recall NDC 65162-757
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Divalproex Sodium (NDC 65162-757). A significant event, classified as Class II, was initiated on Dec 26, 2023 by Amneal Pharmaceuticals Llc. The reported reason for this action was: "Failed dissolution specifications"
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
Dec 26, 2023
Apr 03, 2024
21,452/100 count bottles
Recall Profile & Regulatory Data
Event ID
93976
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Amneal Pharmaceuticals of New York, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide.
Termination Date
Aug 16, 2024
Product Description
Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10
Batch or Lot Expiration Information
Lot# AR210704, exp. date 04/2024 AR210706, exp. date 04/2024 AR210707, exp. date 04/2024 AR210708, exp. date 04/2024 AR210709, exp. date 04/2024
Affected Packages Involved in this Recall
65162-755-10Product
65162-755-50Product
65162-757-10Product
65162-757-50Product
Class II Terminated
Failed dissolution specifications.
Jul 27, 2022
Aug 31, 2022
4,309 bottles
Recall Profile & Regulatory Data
Event ID
90680
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Amneal Pharmaceuticals of New York, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide
Termination Date
Aug 17, 2023
Product Description
Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10
Batch or Lot Expiration Information
Lot# : AR210705, Exp 04/2024
Affected Packages Involved in this Recall
65162-755-10Product
65162-755-50Product
65162-757-10Product
65162-757-50Product
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.
