Quick Facts at a Glance
- Recall Date
- August 7, 2025
- Hazard Level
- HIGH
- Brand
- Glenmark Pharmaceuticals Inc.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, ELDERLY
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
- Glenmark Pharmaceuticals Inc.
- Product type
- Carvedilol Tablets
- Model numbers
- Lot#:19243202, Exp: 7/31/2026
- UPC codes
- 68462-162, 68462-163, 68462-164, 68462-165, 68462-162-60, 68462-162-01, 68462-162-18, 68462-162-05 +6 more
- Sizes
- 12.5 mg
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 7, 2025
Reported by FDA DRUG
August 20, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
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
Carvedilol tablets are a beta-blocker used to treat high blood pressure and heart failure. They are prescribed by physicians and dispensed by pharmacies.
Why This Is Dangerous
Nitrosamine impurities are potential carcinogens. Elevated levels in carvedilol could pose long-term health risks with chronic exposure.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Immediate stop-use is required. Patients may need to switch therapies and manage supply through healthcare providers.
Practical Guidance
How to identify if yours is affected
- Check Lot#: 19243202 and Exp: 7/31/2026.
- Confirm bottle is a 500-count carvedilol tablet bottle, 12.5 mg.
Where to find product info
NDC on bottle label; lot code and expiry printed on the bottle
What timeline to expect
Refunds or replacement details will be provided via recall communications; expect weeks for processing
If the manufacturer is unresponsive
- Contact FDA consumer complaint portal
- Reach out to Glenmark Pharmaceuticals, Inc., USA for escalation
How to prevent similar issues
- Check for CGMP deviations in all prescription medications during recalls
- Verify NDC numbers and lot codes before safekeeping new prescriptions
- Consult pharmacist if unsure about a product's recall status
Documentation advice
Keep copy of recall notice, bottle label, lot number, expiry, and any correspondence with the company
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Product Details
NDC 68462-164-05. 12.5 mg carvedilol tablets, 500-count bottles. Manufactured by Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa, India. Distributed by Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. Quantity: 6,432 bottles. Sold nationwide in the USA. Expiry seen on lot: 7/31/2026. Lot number: 19243202.
Reported Incidents
No specific patient injuries or adverse events are reported in the recall notice. The FDA enforcement listing indicates a high-hazard impurity concern.
Key Facts
- Manufactured in India for Glenmark Pharmaceuticals, Inc., USA
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Safety Guide
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