FDA recall D-0345-2025

Glenmark Pharmaceuticals Inc., USA · Class II · drug

Product

Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), 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

U.S. Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-03-13
Report date: 2025-04-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0345-2025