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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, GLENMARK PHARMACEUTICALS INC., USA
- Product type
- Bisoprolol Fumarate and Hydrochlorothiazide Tablets
- Model numbers
- Lot #: (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 +2 more
- UPC codes
- 68462-878, 68462-879, 68462-880, 68462-878-30, 68462-878-01, 68462-878-05, 68462-879-30, 68462-879-01 +4 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 21, 2025
Reported by FDA DRUG
December 10, 2025
RecallRadar source check
April 13, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Look for the lot numbers: Lot 17232401 or Lot 17240974.
- 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.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
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
- Contamination with ezetimibe
- Stop using product immediately
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
