What is NNCI impurity and why is it a concern?

NNCI stands for N-Nitroso Carvedilol Impurity-1. It was found above FDA-recommended limits in this product, prompting the recall. Health professionals may weigh exposure risks.

Which lots are affected?

Lot T05693 is identified in the recall with Expiration 03/2026.

Should I stop using carvedilol now?

Yes. Stop using the product and consult your healthcare provider for alternatives.

Where can I get more information or a replacement?

Refer to the recall notice and contact Major Pharmaceuticals or Rugby Laboratories for guidance.

Is there a money-back guarantee?

Recall communications typically provide instructions via letters; contact the distributor for refund/replacement details.

What should healthcare providers do?

Review patient exposure and consider guidance from FDA enforcement actions.

Will there be a substitution or alternative therapy?

Clinicians may prescribe a different carvedilol lot or another beta-blocker based on patient needs.

How long will processing take?

Refund/replacement timelines vary; follow recall notification letters.

Can the product be used if it looks normal?

Do not use until guidance is provided by the distributor or healthcare provider.

Where is the product distributed?

Distributed nationwide in the United States as per recall notice.

HIGHAugust 20, 2025

Carvedilol Tablets 12.5 mg Recall Expanded for NNCI Impurity Above FDA Limit (2025)

The FDA recalls 26,628 cartons of Carvedilol Tablets USP 12.5 mg distributed nationwide. The product fails CGMP standards due to NNCI impurity exceeding FDA limits. Stop using and contact The Harvard Drug Group LLC and Rugby Laboratories for guidance.

Quick Facts at a Glance

Recall Date: August 20, 2025
Hazard Level: HIGH
Brands: Major Pharmaceuticals, CARVEDILOL
Category: Health & Personal Care
Sold At: Unknown
Geographic Scope: 1 states
At-Risk Groups: GENERAL, PREGNANT

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 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories or your healthcare provider for guidance. Notification method: Letter

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About This Product

Carvedilol is a beta-blocker used to treat high blood pressure and heart failure. Manufacturers distribute in tablet form to patients nationwide.

Why This Is Dangerous

NNCI impurity above FDA limits could pose health risks; exact clinical implications depend on exposure and patient factors.

Industry Context

This recall is not described as part of a broader pattern in the provided data.

Real-World Impact

The recall requires patients and healthcare providers to review exposure, discontinue use where advised, and coordinate replacements or alternatives.

Practical Guidance

How to identify if yours is affected

Check package for NDC 0904-7307-61
Look for Lot T05693 and Exp. 03/2026
Verify packaging indicates Major Pharmaceuticals and Rugby Laboratories

Where to find product info

FDA recall page linked in enforcement report; manufacturer letters to healthcare providers

What timeline to expect

Processing and guidance to be provided via recall letters; replacements or refunds depend on provider and distributor timelines

If the manufacturer is unresponsive

Escalate to FDA MedWatch
Contact state pharmacy board
Seek guidance from healthcare provider on alternatives

How to prevent similar issues

Verify NDC numbers before dispensing prescriptions
Monitor for NNCI-related recalls in drug databases
Keep patients informed about recall notices

Documentation advice

Keep recall letters, patient exposure records, and communications with pharmacy or provider as documentation

Product Details

Product: Carvedilol Tablets USP, 12.5 mg, 100-tablet carton. Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA. NDC 0904-7307-61. Lot: T05693. Expiration: 03/2026. Quantity: 26,628 cartons. Distribution: Nationwide in the United States.

Reported Incidents

No specific patient incidents or injuries are detailed in the recall notice. Hazard is chemical impurity risk; no incident counts provided.

Key Facts

26,628 cartons recalled
NDC 0904-7307-61
Lot T05693
Exp. Date 03/2026
NNCI impurity above 4.0 ppm
CGMP deviation

View Original Recall on FDA - Drug Safety

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Safety Guide

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERALPREGNANT

Injury Types

POISONINGOTHER

Product Classification

CategoryHealth & Personal Care › Drugs & Medications

Product TypeCarvedilol Tablets 12.5 mg

Product Details

Brands

Major Pharmaceuticals CARVEDILOL

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