FDA recall D-0199-2026

Glenmark Pharmaceuticals Inc., USA · Class III · drug

Product

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.

Reason for recall

Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2025-11-21
Report date
2025-12-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Elmwood Park, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0199-2026