FDA recall D-0333-2025

Glenmark Pharmaceuticals Inc., USA · Class II · drug

Product

Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), 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

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-0333-2025