Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Glenmark Carvedilol Tablets Recalled for Impurity Above Recommended Limit

Agency Publication Date: August 14, 2025
Share:
Sign in to monitor this recall

Summary

Glenmark Pharmaceuticals Inc., USA is recalling approximately 32,472 bottles of Carvedilol (generic Coreg) tablets in 12.5 mg and 25 mg strengths. The recall was initiated because test results found an impurity called N-Nitroso Carvedilol Impurity-1 (NNCI) at levels that exceed the FDA-recommended limit. Affected products include 17,496 bottles of the 12.5 mg dose and 14,976 bottles of the 25 mg dose, all with an expiration date of June 2026.

Risk

The impurity found, NNCI, is a type of nitrosamine. While everyone is exposed to some nitrosamines, long-term exposure to levels above the recommended limit may increase the risk of cancer. To date, there have been no reports of illnesses or injuries related to this specific recall.

What You Should Do

  1. This recall affects Glenmark brand Carvedilol Tablets, USP, in 12.5 mg and 25 mg strengths, sold in 500-count bottles for prescription use.
  2. Identify 12.5 mg tablets by checking for NDC 68462-164-05 and lot numbers 17241257, 17241258, or 17241279 with an expiration date of 06/2026.
  3. Identify 25 mg tablets by checking for NDC 68462-165-05 and lot numbers 17241213, 17241215, or 17241224 with an expiration date of 06/2026.
  4. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Carvedilol Tablets, USP, 12.5 mg
Variants: 12.5 mg, 500 Tablets per carton
Lot Numbers:
17241257 (Exp 06/2026)
17241258 (Exp 06/2026)
17241279 (Exp 06/2026)
NDC:
68462-164-05

Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430

Product: Carvedilol Tablets, USP, 25 mg
Variants: 25 mg, 500 Tablets per carton
Lot Numbers:
17241213 (Exp 06/2026)
17241215 (Exp 06/2026)
17241224 (Exp 06/2026)
NDC:
68462-165-05

Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97372
Status: Active
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Sold By: Retail pharmacies; Wholesale distributors
Manufactured In: India, United States
Units Affected: 2 products (17, 496 bottles; 14,976 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.