Class IIIOngoing

Bisoprolol Fumarate and Hydrochlorothiazide Tablets recall

FDA recall D-0199-2026 · initiated Nov 21, 2025

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

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

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.
Recalling company: Glenmark Pharms
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: Nov 21, 2025
FDA report date: Dec 10, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0199-2026 ↗

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