Glenmark Pharmaceuticals Inc., USA recalls Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-8…

Recall date

November 21, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0199-2026

FDA classification

Class III

Brand / firm

Glenmark Pharmaceuticals Inc., USA

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.