Glenmark Pharmaceuticals recalled over 11,000 bottles of Bisoprolol Fumarate and Hydrochlorothiazide Tablets on November 21, 2025. Testing revealed traces of ezetimibe, posing a health risk. Consumers should stop using the product immediately and contact their healthcare provider.
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Consumers and healthcare providers should stop using this product immediately. Contact Glenmark Pharmaceuticals Inc., USA or your healthcare provider for guidance. Notification method: Letter
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The recall includes Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg. Affected packaging includes 30-count bottles (NDC-68462-878-30), 100-count bottles (NDC-68462-878-01), and 500-count bottles (NDC-68462-878-05). These products were distributed nationwide in the USA.
Testing of reserve samples showed contamination with traces of ezetimibe. This contamination can pose serious health risks, especially for individuals allergic to ezetimibe.
There have been no reported injuries or deaths related to this recall. The contamination is classified as a high hazard due to the potential health risks.
Stop using the affected Bisoprolol Tablets immediately. Contact Glenmark Pharmaceuticals Inc., USA or your healthcare provider for guidance on next steps.
For more information, consumers can visit the FDA recall page at [FDA Recall Information](https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0199-2026).
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