Bisoprolol and hydrochlorothiazide tablets recalled for cross-contamination with ezetimibe
Glenmark Pharmaceuticals is recalling certain lots of bisoprolol fumarate and hydrochlorothiazide tablets nationwide due to trace cross-contamination with ezetimibe detected in testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Class III drug recalls are typically scored 1 or 2. No illnesses or injuries are reported in the source, and the contamination consists of traces of an unintended pharmaceutical. This precautionary cross-contamination recall meets the criteria for Moderate severity.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling certain lots of bisoprolol fumarate and hydrochlorothiazide tablets, USP (2.5 mg/6.25 mg), nationwide due to cross-contamination with traces of ezetimibe. The affected lots are Lot 17232401 (expiration 11/2025) and Lot 17240974 (expiration 05/2026), distributed as 30-count, 100-count, and 500-count bottles.
This medication is used to treat high blood pressure. Patients who have bottles from the affected lots should contact their pharmacist or healthcare provider for guidance.
The FDA is monitoring this recall. Consumers with questions may contact Glenmark Pharmaceuticals Inc., USA or report adverse events to the FDA's MedWatch program.
The recalled product
- Product
- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE)
- Brand
- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Antihypertensive Drug
- Hazard
- cross-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: (a): Lot 17232401
- exp 11/2025
- Lot 17240974
- exp 05/2026 (b): Lot 17232401
- exp 05/2026 (c): Lot 17232401
- exp 05/2026
UPCs (3)
- 0368462880302
- 0368462879306
- 0368462878309
Distribution
Distributed nationwide across the United States.
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Same brand · BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
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- ModerateBisoprolol Fumarate and Hydrochlorothiazide Tablets Recalled for Failed Quality Specifications
FDA (Drugs) · 2023-11-08
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