Glenmark Pharmaceuticals Inc., USA recalls Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-87
Recalled December 10, 2025 · FDA recall D-0199-2026 · Glenmark Pharmaceuticals Inc., USA
Hazard
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe · FDA Class III
Units
11,136 bottles
Sold at
Nationwide in the USA
Description
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
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.
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →