Quick Facts at a Glance
- Recall Date
- August 7, 2025
- Hazard Level
- HIGH
- Brands
- Glenmark Pharmaceuticals, CARVEDILOL
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- NDC 68462-162-05, NDC 68462-162-01, Lot#: 19242274, Lot#: 19242275, Lot#: 19242272, Exp: 5/31/20, Exp: 5/31/2026
- 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
- 500-count, 100-count
- Sold at
- Unknown
- 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 used to treat high blood pressure and heart failure. This 3.125 mg dose comes in standard Rx packaging.
Why This Is Dangerous
Nitrosamines are potential carcinogens. The impurity exceeds acceptable intake levels, prompting CGMP deviations in manufacturing.
Industry Context
This recall is part of ongoing CGMP-related nitrosamine surveillance in regulated drug manufacturing.
Real-World Impact
The recall affects patients who rely on carvedilol for cardiovascular conditions, requiring them to stop use and seek medical guidance.
Practical Guidance
How to identify if yours is affected
- 1. Locate the bottle NDC on the label (68462-162-05 or 68462-162-01).
- 3. Confirm packaging type (500-count or 100-count bottle).
Where to find product info
FDA recall page and Glenmark patient letters; label details on each bottle.
What timeline to expect
Refund/replacement timelines vary; check with Glenmark for specifics.
If the manufacturer is unresponsive
- Document all attempts to contact Glenmark.
- File a MedWatch adverse event report if you experience symptoms.
- Consult your pharmacist for interim treatment guidance.
How to prevent similar issues
- Verify CGMP compliance when choosing generic carvedilol.
- Ask healthcare providers about nitrosamine-related recalls.
- Keep updated with FDA recall notices.
Documentation advice
Retain recall notices, label copies, and pharmacy communications; document dates and contacts.
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Product Details
Product: Carvedilol Tablets, USP 3.125 mg. Packaging: 500-count bottle NDC 68462-162-05; 100-count bottle NDC 68462-162-01. Rx only. Manufactured by Glenmark Pharmaceuticals Ltd, Colvale-Bardez Goa, India. Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA. Quantity: 44,328 bottles. Sold nationwide in the USA.
Reported Incidents
No specific injuries or incidents are reported in the dataset.
Key Facts
- Manufactured in India for US distribution
- Nitrosamine impurity exceeding intake guidelines
- Recall status: ACTIVE
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Safety Guide
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