Medications & Supplements/Prescription Drugs

Major Pharmaceuticals Carvedilol Tablets Recalled for Excessive Impurity

Agency Publication Date: August 21, 2025

Summary

The Harvard Drug Group LLC is recalling 26,628 cartons of Major Pharmaceuticals brand Carvedilol (carvedilol) Tablets USP, 12.5 mg. The recall was issued because testing found levels of an impurity known as N-Nitroso Carvedilol Impurity-1 (NNCI) that exceed the FDA-recommended safety limit of 4.0 ppm. Affected units are packaged in 100-count cartons (10x10 configuration) and were distributed nationwide.

Risk

The product contains levels of NNCI higher than recommended safety standards. Nitrosamine impurities like NNCI are classified as potential human carcinogens, meaning long-term exposure above safety limits may increase the risk of cancer.

What You Should Do

The recalled products are 100-count cartons (10x10) of Major Pharmaceuticals Carvedilol Tablets USP, 12.5 mg (NDC 0904-7307-61) identified by lot number T05693 and an expiration date of 03/2026.
If you have health concerns about this medication, contact your healthcare provider or pharmacist for guidance before making any changes to your treatment.
Return any unused product to the place of purchase for a refund, throw it away, or contact The Harvard Drug Group LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

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 (100-count)by Major Pharmaceuticals

Variants: 12.5 mg, Tablet

Lot Numbers:

T05693 (Exp 03/2026)

NDC:

0904-7307-61

Packaged in (10x10) cartons; Rx Only.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97449

Status: Active

Manufacturer: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 26,628 cartons

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 · 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

The recalled products are 100-count cartons (10x10) of Major Pharmaceuticals Carvedilol Tablets USP, 12.5 mg (NDC 0904-7307-61) identified by lot number T05693 and an expiration date of 03/2026.

If you have health concerns about this medication, contact your healthcare provider or pharmacist for guidance before making any changes to your treatment.

Return any unused product to the place of purchase for a refund, throw it away, or contact The Harvard Drug Group LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.