Quick Facts at a Glance
- Recall Date
- August 7, 2025
- Hazard Level
- HIGH
- Brands
- Glenmark Pharmaceuticals, CARVEDILOL
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
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, CARVEDILOL
- Product type
- Carvedilol tablets
- Model numbers
- Lot#:19243104, Expires: 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
- 25 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 is a beta-blocker used for cardiovascular conditions and is dispensed Rx-only in 500-count bottles.
Why This Is Dangerous
Nitrosamine impurity exceeds Acceptable Intake Level, CGMP deviations raise potential safety concerns.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Requires immediate discontinuation from patient regimens; potential regulatory and safety concerns for patients on carvedilol.
Practical Guidance
How to identify if yours is affected
- Look for Lot#: 19243104 on the bottle
- Check expiration date 7/31/2026
- Verify country of manufacture: India
Where to find product info
FDA recall page and Glenmark notice; look for the D-0579-2025 identifier
What timeline to expect
Notification letters to patients and healthcare providers; refunds or replacements issued per company process
If the manufacturer is unresponsive
- Keep copies of all communications
- Contact FDA consumer complaint line if no response after the recall notice
How to prevent similar issues
- Verify NDC before dispensing or purchasing carvedilol
- Ask clinicians about recalled lots before renewing prescriptions
- Monitor for nitrosamine-related recalls in other medications
Documentation advice
Retain recall letter, photos of bottle and label, prescription records, and all communications
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Product: Carvedilol Tablets, USP, 25 mg, 500-count bottle. Manufacturer: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ. NDC 68462-165-05. Quantity recalled: 4,800 bottles. Distribution: Nationwide in the USA. Status: Active recall as of 2025-08-07.
Reported Incidents
No specific injuries or adverse events are detailed in the recall notice.
Key Facts
- N-Nitroso Carvedilol I impurity above AIIL
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.