FDA Recall D-0199-2026

Glenmark Pharmaceuticals Inc., USA · Elmwood Park, NJ

Class III Ongoing 174 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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.

Lot / code: 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

Quantity: 11,136 bottles

Reason for recall

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

Recall record

Recall number: D-0199-2026
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-11-21
Classified by FDA Center: 2025-12-01
FDA published: 2025-12-10
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Firm location: Elmwood Park, NJ

Drug identification

Brand name(s): BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Generic name(s): BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Manufacturer(s): GLENMARK PHARMACEUTICALS INC., USA
NDC(s): 68462-878, 68462-879, 68462-880
Route(s): ORAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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