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FDARecalled Dec 10, 2025 · #D-0199-2026

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-6846...

Hazard

Class III — low health risk

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Description

Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe Classification: Class III Distribution: Nationwide in the USA

Product details

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.
Type
Drugs
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Model numbers
17232401, 17240974
UPCs