Bisoprolol and hydrochlorothiazide tablets recalled over traces of another drug
Glenmark Pharmaceuticals is recalling 11,136 bottles of Bisoprolol Fumarate and Hydrochlorothiazide Tablets after reserve sample testing showed traces of ezetimibe.
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: Scored 2 under the rule that FDA Class III actions fall at 1 or 2: the record cites traces of another drug found in reserve samples, with no stated clinical consequence.
Plain-English summary
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, are being recalled. The prescription product was supplied in 30-count bottles (NDC 68462-878-30), 100-count bottles (NDC 68462-878-01) and 500-count bottles (NDC 68462-878-05). It is manufactured by Glenmark Pharmaceuticals Limited in Pithampur, Madhya Pradesh, India, for Glenmark Pharmaceuticals, Inc., USA of Mahwah, New Jersey.
The recall follows cross contamination with other products: testing of reserve samples showed the presence of traces of ezetimibe.
The recall covers 11,136 bottles from lots 17232401, expiry 11/2025, and 17240974, expiry 05/2026, across all three bottle counts. Distribution was nationwide in the USA. The FDA has classified the action as Class III, its least serious category.
Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected and arrange a replacement.
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
- Affected units
- 11,136
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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