← FDA ENFORCEMENT
D-0199-2026Class III

Glenmark Pharmaceuticals Inc., USA

Recalling firm
Glenmark Pharmaceuticals Inc., USA
Product type
Drug
Status
Ongoing
Report date
2025-12-10
Distribution
Nationwide in the USA
Firm state
NJ
Product quantity
11,136 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Product description

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.

Code / lot 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

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See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.