Quick Facts at a Glance
- Recall Date
- August 6, 2025
- Hazard Level
- HIGH
- Brands
- Glenmark Pharmaceuticals Inc., Glenmark Pharmaceuticals Ltd.
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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., Glenmark Pharmaceuticals Ltd.
- Product type
- Carvedilol Tablets
- Model numbers
- Lot #: 17241257, 17241258, 17241279
- 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
- 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. This recall concerns impurities in the product rather than a device malfunction.
Why This Is Dangerous
NNCI impurity above FDA limits may pose health risks. The exact health effects are not specified in the notice.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Immediate halting of use is advised. Affects patients currently prescribed carvedilol with these lots.
Practical Guidance
How to identify if yours is affected
- Check NDC 68462-164-05 on the bottle.
- Verify packaging shows Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430.
Where to find product info
FDA enforcement page for D-0587-2025 and Glenmark recall notices.
What timeline to expect
Refunds/replacements follow manufacturer processes, typically weeks to a few months.
If the manufacturer is unresponsive
- Escalate to FDA consumer complaint portal
- Consult your healthcare provider for alternatives
How to prevent similar issues
- Verify NDC numbers before fill
- Stay alert for recall notices from FDA
- Discuss substitutions with prescriber
Documentation advice
Keep recall letter, prescription records, bottle labels, and correspondence with manufacturer.
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Product Details
Product: Carvedilol Tablets, USP 12.5 mg. Quantity: 17,496 bottles. Manufacturer: Glenmark Pharmaceuticals Ltd., India. Distributed by Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430. NDC 68462-164-05. Lot numbers: 17241257, 17241258, 17241279. Expiration: 06/2026. Distribution: Nationwide in the USA. Status: Active recall as of 2025-08-06.
Reported Incidents
No specific consumer injuries or adverse event reports are mentioned in the recall notice.
Key Facts
- NNCI impurity above FDA limit (4.0 ppm)
- Active recall (D-0587-2025)
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Safety Guide
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