Glenmark Pharmaceuticals Inc., USA: Drug Recall

Recall #D-0112-2024 · 10/23/2023

Class III: Low Risk

Recall Details

Recall Number: D-0112-2024
Classification: Class III
Product Type: Drug
Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Status: Terminated
Date Initiated: 10/23/2023
Location: Mahwah, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8,448 30-count bottles, 168 1000-count bottles

Reason for Recall

Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).

Product Description

Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India,

Distribution Pattern

Nationwide in the USA

Other Recalls by Glenmark Pharmaceuticals Inc., USA

Class II: Risk 12/30/2025

Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class III: Low Risk 11/21/2025

Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Class III: Low Risk 11/18/2025

Cross Contamination with Other Products
Class II: Risk 09/17/2025

CGMP Deviations: Market complaints received for gritty texture (grainy)
Class II: Risk 09/03/2025

Failed Impurities/Degradation Specifications

View all recalls by Glenmark Pharmaceuticals Inc., USA →

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.