Amneal Pharmaceuticals of New York, LLC: Drug Recall

Recall #D-0426-2024 · 12/26/2023

Class II: Risk

Recall Details

Recall Number: D-0426-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Amneal Pharmaceuticals of New York, LLC
Status: Terminated
Date Initiated: 12/26/2023
Location: Brookhaven, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 21,452/100 count bottles

Reason for Recall

Failed dissolution specifications

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

Distribution Pattern

Product was distributed nationwide.

Other Recalls by Amneal Pharmaceuticals of New York, LLC

Class II: Risk 03/25/2024

Failed Dissolution Specifications
Class I: Dangerous 03/21/2024

Superpotent Drug: Due to overfilling of drug powder
Class II: Risk 02/13/2024

Failed Impurities/Degradation Specifications: Out-of-specification test results.
Class II: Risk 01/15/2024

Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Class II: Risk 10/27/2023

Failed Dissolution Specifications

View all recalls by Amneal Pharmaceuticals of New York, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.