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Class III · Lower riskActive recall

Bisoprolol Fumarate And Hydrochlorothiazide

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: (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
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byGlenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430
Brand nameBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Generic nameBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Active ingredient(s)BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE
Distributed by / forGlenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430
NDC-68462-878-30
Show the full FDA record
Full product labelBisoprolol 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 firmGlenmark Pharmaceuticals Inc., USA
DistributionNationwide in the USA
Quantity11,136 bottles
Recall initiated2025-11-21
Report date2025-12-10
Recall completed—
Recall numberD-0199-2026
ClassificationClass III
FDA statusOngoing
Origin on fileElmwood Park NJ United States

Related

Hydrochlorothiazide recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.