Home / Recalls / Glenmark Pharmaceuticals Inc., USA / D-0332-2025

D-0332-2025 Class II Ongoing

Recalled by Glenmark Pharmaceuticals Inc., USA — Mahwah, NJ

Recall Details

Product Type
Drugs
Report Date
April 16, 2025
Initiation Date
March 13, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.

Reason for Recall

CGMP Deviations

Distribution Pattern

U.S. Nationwide

Code Information

Lot # 17232460, exp. date Nov-25 17232460, exp. date Nov-25 17241194, exp. date Jun-26 17241194, exp. date Jun-26

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  • D-0578-2025 Class II — Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Gl (August 7, 2025)
  • D-0587-2025 Class II — Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured (August 6, 2025)