WhichRecall
Class IIIReported 2025-12-10

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.

Recalled by Glenmark Pharmaceuticals Inc., USA

Reason for Recall

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

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Recall Number
D-0199-2026
Classification
Class III
Status
Ongoing
Category
drug
Initiated
2025-11-21
Reported
2025-12-10
Distribution
Nationwide in the USA
Code Info
Lot #: (a): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (b): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (c): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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