HIGH

Glenmark Pharmaceuticals Recalls Bisoprolol Tablets Due to Contamination

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.

Quick Facts at a Glance

Recall Date
November 21, 2025
Hazard Level
HIGH
Brands
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, GLENMARK PHARMACEUTICALS INC., USA
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

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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About This Product

Bisoprolol Fumarate and Hydrochlorothiazide Tablets are used to treat high blood pressure and heart failure. Consumers typically buy this medication to manage cardiovascular health and improve overall wellbeing.

Why This Is Dangerous

Cross-contamination with ezetimibe can lead to unexpected side effects for those who are allergic or sensitive to that medication. This poses a significant health risk for users who may inadvertently consume it.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may face health risks if they continue to use the affected product. The urgency to stop using the medication is high due to potential allergic reactions.

Practical Guidance

How to identify if yours is affected

  1. Check the bottle for the NDC number: 68462-878-30, 68462-878-01, or 68462-878-05.
  2. Look for the lot numbers: Lot 17232401 or Lot 17240974.
  3. Verify the expiration dates: 11/2025 or 05/2026.

Where to find product info

The NDC number can typically be found on the prescription label or packaging.

What timeline to expect

Expect processing for refunds or replacements to take approximately 4-6 weeks.

If the manufacturer is unresponsive

  • Document all communication attempts with the manufacturer.
  • Consider filing a complaint with the FDA if unresponsive.
  • Reach out to your healthcare provider for assistance.

How to prevent similar issues

  • Consult with your healthcare provider before starting any new medication.
  • Always check for recalls or safety alerts before using medications.
  • Verify the source of medications to ensure they are from reputable manufacturers.

Documentation advice

Keep copies of any receipts, correspondence with the manufacturer, and photos of the product for your records.

Product Details

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.

Key Facts

  • Recall date: November 21, 2025
  • 11,136 bottles affected
  • Contamination with ezetimibe
  • Stop using product immediately

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeBisoprolol Fumarate and Hydrochlorothiazide Tablets
Sold At
Multiple Retailers

Product Details

Model Numbers
Lot #: (a): Lot 17232401
exp 11/2025
Lot 17240974
exp 05/2026 (b): Lot 17232401
exp 11/2025
+5 more
UPC Codes
68462-878
68462-879
68462-880
+9 more
Affected States
ALL
Report Date
December 10, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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