Quick Facts at a Glance
- Recall Date
- August 6, 2025
- Hazard Level
- HIGH
- Brands
- CARVEDILOL, Glenmark Pharmaceuticals Inc., USA
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- CARVEDILOL, Glenmark Pharmaceuticals Inc., USA
- Product type
- Carvedilol Tablets
- Model numbers
- Lot #: 17241213, 17241215, 17241224
- UPC codes
- 68462-162, 68462-163, 68462-164, 68462-165, 68462-162-60, 68462-162-01, 68462-162-18, 68462-162-05 +6 more
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 6, 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: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
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 is a beta-blocker used to treat high blood pressure and heart failure. Consumers may be prescribed or dispense it as a generic or brand medication.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Low immediate safety risk but potential long-term cancer risk with chronic exposure. Affects patients currently taking carvedilol with this lot.
Practical Guidance
How to identify if yours is affected
- Obtain bottle with NDC 68462-165-05
- Verify Expiration Date 06/2026
- Cease use immediately if match found
Where to find product info
Label on carton and bottle shows NDC, lot, and expiration. FDA recall page provides details.
What timeline to expect
Recall notices by letter; refunds or replacements processed per company policy within 4-8 weeks.
If the manufacturer is unresponsive
- Escalate to patient safety or regulatory bodies
- Document all communications
- Consult healthcare provider for interim guidance
How to prevent similar issues
- Verify NDC and lot numbers before dispensing or taking prescriptions
- Use trusted sources for medication recalls
- Maintain updated patient medication lists
Documentation advice
Keep recall letter, FDA notice, purchase proof, bottle label, and any correspondence.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Brand: CARVEDILOL. Product: Carvedilol Tablets, USP, 25 mg, 500 tablets per carton. Manufactured by Glenmark Pharmaceuticals Ltd., India. Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430. NDC: 68462-165-05. Lot numbers: 17241213, 17241215, 17241224. Expiration: 06/2026. Quantity: 14,976 bottles. Distribution: Nationwide in the USA.
Reported Incidents
No specific injuries or adverse events are detailed in the recall notice.
Key Facts
- 14,976 bottles recalled nationwide
- Manufactured in India for Glenmark USA
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.