Medications & Supplements/Prescription Drugs

Major Pharmaceuticals Chlorpromazine Tablets Recalled for Impurity Risk

Agency Publication Date: April 16, 2025

Summary

Major Pharmaceuticals has recalled 133 cartons of Chlorpromazine Hydrochloride Tablets (10 mg), a medication used to treat certain mental or emotional disorders. The recall was issued because testing found an impurity called N-Nitroso-Desmethyl Chlorpromazine at levels higher than the FDA's recommended limit. The affected product was distributed in cartons of 100 tablets across the United States.

Risk

The impurity found is a nitrosamine, which is a substance that can potentially increase the risk of cancer if people are exposed to levels above recommended limits over a long period of time. No injuries or illnesses have been reported to date.

What You Should Do

This recall affects Chlorpromazine Hydrochloride Tablets, USP, 10 mg, sold in 100-count cartons (NDC 0904-7129-61) under the Major Pharmaceuticals brand.
Identify if your product is affected by checking the packaging for lot number N02114 and an expiration date of 12/31/2025.
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 or visit www.fda.gov/safety/recalls for additional information.

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: ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg (100-count carton)by Major Pharmaceuticals

Variants: 10 mg, Tablet

Lot Numbers:

N02114 (Exp 12/31/2025)

NDC:

0904-7129-61

Packaged in cartons of 100 TABLETS (10x10), Rx only; Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96679

Status: Active

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

Sold By: Major Pharmaceuticals; authorized distributors; pharmacies

Manufactured In: United States

Units Affected: 133 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

This recall affects Chlorpromazine Hydrochloride Tablets, USP, 10 mg, sold in 100-count cartons (NDC 0904-7129-61) under the Major Pharmaceuticals brand.

Identify if your product is affected by checking the packaging for lot number N02114 and an expiration date of 12/31/2025.

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 or visit www.fda.gov/safety/recalls for additional information.

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: ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg (100-count carton)by Major Pharmaceuticals

Variants: 10 mg, Tablet

Lot Numbers:

N02114 (Exp 12/31/2025)

NDC:

0904-7129-61

Packaged in cartons of 100 TABLETS (10x10), Rx only; Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96679

Status: Active

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

Sold By: Major Pharmaceuticals; authorized distributors; pharmacies

Manufactured In: United States

Units Affected: 133 cartons

Distributed To: Nationwide