Glenmark Pharmaceuticals Inc., USA: Drug Recall

Recall #D-0452-2025 · 05/15/2025

Class II: Risk

Recall Details

Recall Number: D-0452-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Status: Ongoing
Date Initiated: 05/15/2025
Location: Mahwah, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8,520 100-count bottles

Reason for Recall

OOS results reported for the Dissolution (by UV) test.

Product Description

Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-356-01

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.