Medications & Supplements/Prescription Drugs

Glenmark Carvedilol Tablets Recalled for Excessive Impurity

Agency Publication Date: May 28, 2025

Summary

Glenmark Pharmaceuticals Inc., USA is recalling 102,944 units of Carvedilol (generic Coreg) tablets in several strengths: 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg. This recall was initiated due to manufacturing deviations that resulted in the presence of an impurity called 'N-Nitroso Carvedilol I' at levels exceeding the recommended intake limits. These products were distributed nationwide in the United States and were manufactured by Glenmark Pharmaceuticals Ltd. in India for Glenmark Pharmaceuticals Inc., USA.

Risk

The impurity found, N-Nitroso Carvedilol I, belongs to a class of substances called nitrosamines, which are classified as probable human carcinogens. Long-term exposure to these impurities above acceptable levels may increase the risk of cancer.

What You Should Do

This recall affects Glenmark Carvedilol Tablets USP in 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg strengths, sold in 100-count and 500-count white plastic bottles.
Check your medication bottle for the following NDC codes: 68462-162-01, 68462-162-05 (3.125 mg); 68462-163-01, 68462-163-05 (6.25 mg); 68462-164-05 (12.5 mg); or 68462-165-05 (25 mg).
Look for lot numbers and expiration dates ranging from February 2025 to January 2026 printed on the label. See the Affected Products section below for the full list of affected codes.
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.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 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

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 3.125mg

Variants: 3.125 mg, Tablet

Lot Numbers:

19231450 (Exp Mar-25)

19233345 (Exp Jul-25)

19234275 (Exp Sep-25)

19240280 (Exp DEC-25)

19231464 (Exp Mar-25)

19231471 (Exp Mar-25)

19231493 (Exp Mar-25)

19232083 (Exp Apr-25)

19232103 (Exp Apr-25)

19232658 (Exp Jun-25)

19233328 (Exp Jul-25)

19233343 (Exp Jul-25)

19233344 (Exp Jul-25)

19234843 (Exp Nov-25)

19235039 (Exp Nov-25)

19240296 (Exp Dec-25)

NDC:

68462-162-01

68462-162-05

Distributed in 100-count and 500-count bottles.

Product: Carvedilol Tablets USP 6.25 mg

Variants: 6.25 mg, Tablet

Lot Numbers:

19231618 (exp Mar-25)

19232064 (exp Apr-25)

19232324 (exp May-25)

19233369 (Exp Jul-25)

19234162 (Exp Sep-25)

19240543 (Exp Jan-26)

19231174 (Exp Feb-25)

19231199 (Exp Feb-25)

19231164 (Exp Feb-25)

19231517 (Exp Mar-25)

19231527 (Exp Mar-25)

19231566 (Exp Mar-25)

19231568 (Exp Mar-25)

19231595 (Exp Mar-25)

19231634 (Exp Mar-25)

19231638 (Exp Mar-25)

19231448 (Exp Mar-25)

19232043 (Exp Apr-25)

19232051 (Exp Apr-25)

19232322 (Exp May-25)

19232365 (Exp May-25)

19232380 (Exp May-25)

19232389 (Exp May-25)

19232736 (Exp Jun-25)

19232743 (Exp Jun-25)

19232746 (Exp Jun-25)

19232756 (Exp Jun-25)

19232757 (Exp Jun-25)

19233371 (Exp Jul-25)

19233405 (Exp Jul-25)

19233416 (Exp Jul-25)

19234183 (Exp Sep-25)

19234192 (Exp Sep-25)

19234204 (Exp Sep-25)

19234223 (Exp Sep-25)

19234243 (Exp Sep-25)

19234263 (Exp Sep-25)

19234165 (Exp Sep-25)

19234242 (Exp Sep-25)

19234743 (Exp Nov-25)

19234774 (Exp Nov-25)

19234993 (Exp Nov-25)

19240223 (Exp Dec-25)

19240203 (Exp Dec-25)

19240211 (Exp Dec-25)

19240214 (Exp Dec-25)

19240247 (Exp Dec-25)

19240249 (Exp Dec-25)

19240272 (Exp Dec-25)

19240319 (Exp Dec-25)

NDC:

68462-163-01

68462-163-05

Distributed in 100-count and 500-count bottles.

Product: Carvedilol Tablets USP 12.5 mg

Variants: 12.5 mg, Tablet

Lot Numbers:

19231899 (Exp Apr-25)

19231922 (Exp Apr-25)

19231927 (Exp Apr-25)

19231967 (Exp Apr-25)

19231979 (Exp Apr-25)

19232226 (Exp May-25)

19232234 (Exp May-25)

19232265 (Exp May-25)

19232271 (Exp May-25)

19232758 (Exp Jun-25)

19232759 (Exp Jun-25)

19232762 (Exp Jun-25)

19232788 (Exp Jun-25)

NDC:

68462-164-05

Distributed in 500-count bottles.

Product: Carvedilol Tablets USP 25 mg

Variants: 25 mg, Tablet

Lot Numbers:

19231107 (Exp Feb-25)

19231114 (Exp Feb-25)

19231152 (Exp Feb-25)

19234866 (Exp Jan-26)

NDC:

68462-165-05

Distributed in 500-count bottles.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96861

Status: Active

Manufacturer: Glenmark Pharmaceuticals Inc., USA

Sold By: Retail Pharmacies

Manufactured In: India

Units Affected: 4 products ([100 Tablet Bottles] 59,952 bottles; [500 Tablet Bottles] 155,976 bottles; [100 Tablet Bottles] 90,000 bottles; [500 Tablet Bottles] 324,288 bottles; 84,048 bottles; 18,696 bottles)

Distributed To: Nationwide

Agency Last Updated: June 10, 2025

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 · 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.

Summary

What You Should Do

This recall affects Glenmark Carvedilol Tablets USP in 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg strengths, sold in 100-count and 500-count white plastic bottles.

Check your medication bottle for the following NDC codes: 68462-162-01, 68462-162-05 (3.125 mg); 68462-163-01, 68462-163-05 (6.25 mg); 68462-164-05 (12.5 mg); or 68462-165-05 (25 mg).

Look for lot numbers and expiration dates ranging from February 2025 to January 2026 printed on the label. See the Affected Products section below for the full list of affected codes.

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.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 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

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 3.125mg

Variants: 3.125 mg, Tablet

Lot Numbers:

19231450 (Exp Mar-25)

19233345 (Exp Jul-25)

19234275 (Exp Sep-25)

19240280 (Exp DEC-25)

19231464 (Exp Mar-25)

19231471 (Exp Mar-25)

19231493 (Exp Mar-25)

19232083 (Exp Apr-25)

19232103 (Exp Apr-25)

19232658 (Exp Jun-25)

19233328 (Exp Jul-25)

19233343 (Exp Jul-25)

19233344 (Exp Jul-25)

19234843 (Exp Nov-25)

19235039 (Exp Nov-25)

19240296 (Exp Dec-25)

NDC:

68462-162-01

68462-162-05

Distributed in 100-count and 500-count bottles.

Product: Carvedilol Tablets USP 6.25 mg

Variants: 6.25 mg, Tablet

Lot Numbers:

19231618 (exp Mar-25)

19232064 (exp Apr-25)

19232324 (exp May-25)

19233369 (Exp Jul-25)

19234162 (Exp Sep-25)

19240543 (Exp Jan-26)

19231174 (Exp Feb-25)

19231199 (Exp Feb-25)

19231164 (Exp Feb-25)

19231517 (Exp Mar-25)

19231527 (Exp Mar-25)

19231566 (Exp Mar-25)

19231568 (Exp Mar-25)

19231595 (Exp Mar-25)

19231634 (Exp Mar-25)

19231638 (Exp Mar-25)

19231448 (Exp Mar-25)

19232043 (Exp Apr-25)

19232051 (Exp Apr-25)

19232322 (Exp May-25)

19232365 (Exp May-25)

19232380 (Exp May-25)

19232389 (Exp May-25)

19232736 (Exp Jun-25)

19232743 (Exp Jun-25)

19232746 (Exp Jun-25)

19232756 (Exp Jun-25)

19232757 (Exp Jun-25)

19233371 (Exp Jul-25)

19233405 (Exp Jul-25)

19233416 (Exp Jul-25)

19234183 (Exp Sep-25)

19234192 (Exp Sep-25)

19234204 (Exp Sep-25)

19234223 (Exp Sep-25)

19234243 (Exp Sep-25)

19234263 (Exp Sep-25)

19234165 (Exp Sep-25)

19234242 (Exp Sep-25)

19234743 (Exp Nov-25)

19234774 (Exp Nov-25)

19234993 (Exp Nov-25)

19240223 (Exp Dec-25)

19240203 (Exp Dec-25)

19240211 (Exp Dec-25)

19240214 (Exp Dec-25)

19240247 (Exp Dec-25)

19240249 (Exp Dec-25)

19240272 (Exp Dec-25)

19240319 (Exp Dec-25)

NDC:

68462-163-01

68462-163-05

Distributed in 100-count and 500-count bottles.

Product: Carvedilol Tablets USP 12.5 mg

Variants: 12.5 mg, Tablet

Lot Numbers:

19231899 (Exp Apr-25)

19231922 (Exp Apr-25)

19231927 (Exp Apr-25)

19231967 (Exp Apr-25)

19231979 (Exp Apr-25)

19232226 (Exp May-25)

19232234 (Exp May-25)

19232265 (Exp May-25)

19232271 (Exp May-25)

19232758 (Exp Jun-25)

19232759 (Exp Jun-25)

19232762 (Exp Jun-25)

19232788 (Exp Jun-25)

NDC:

68462-164-05

Distributed in 500-count bottles.

Product: Carvedilol Tablets USP 25 mg

Variants: 25 mg, Tablet

Lot Numbers:

19231107 (Exp Feb-25)

19231114 (Exp Feb-25)

19231152 (Exp Feb-25)

19234866 (Exp Jan-26)

NDC:

68462-165-05

Distributed in 500-count bottles.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96861

Status: Active

Manufacturer: Glenmark Pharmaceuticals Inc., USA

Sold By: Retail Pharmacies

Manufactured In: India

Distributed To: Nationwide

Agency Last Updated: June 10, 2025