What should I do if I have Chlorpromazine Hydrochloride Tablets?

Stop using the tablets immediately. Consult your healthcare provider to discuss alternative treatments and next steps.

How can I identify if my Chlorpromazine Tablets are part of the recall?

Check the lot numbers Z403011 or Z407335 and their expiration dates of 30-04-26 or 30-11-26. If you own these, discontinue use.

What health risks are associated with N-Nitroso Desmethyl Chlorpromazine?

N-Nitroso Desmethyl Chlorpromazine is a potential carcinogen. Exposure to elevated levels may affect your health significantly.

Where can I find more information about this recall?

Visit the FDA’s website for detailed information and updates on the recall.

Can I return my recalled Chlorpromazine?

Yes, you should contact Zydus Pharmaceuticals for guidance on how to return the product for a refund.

Is there a recall on all Chlorpromazine products?

The recall specifically pertains to certain lots of Chlorpromazine Hydrochloride Tablets from Zydus Lifesciences. Always check your product details.

What are the symptoms of exposure to N-Nitroso compounds?

Symptoms may vary widely based on exposure and health conditions. It is best to consult a healthcare professional if you suspect exposure.

Are there alternative medications I can use?

Consult your healthcare provider for suitable alternatives such as Cariprazine, Olanzapine, or Quetiapine.

How long will it take to process my refund for the recalled product?

Typically, refund processing may take around 4-6 weeks. Ensure you keep relevant documents like receipts.

What if I experience health issues related to this product?

Seek immediate medical attention if you experience any adverse health effects after using the recalled product.

HIGHSeptember 3, 2025

Zydus Lifesciences Chlorpromazine Hydrochloride Tablets Recalled for N-nitroso Contamination

Zydus Lifesciences recalled an undisclosed number of Chlorpromazine Hydrochloride Tablets due to N-nitroso desmethyl chlorpromazine contamination. Laboratory tests detected this chemical above the acceptable intake limit posing serious health risks. Consumers must stop using the tablets immediately and consult with healthcare providers for guidance.

Quick Facts at a Glance

Recall Date: September 3, 2025
Hazard Level: HIGH
Brands: Zydus Lifesciences, Northstar Rx LLC
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 1 states
At-Risk Groups: GENERAL

Hazard Information

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: N/A

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

About This Product

Chlorpromazine Hydrochloride Tablets are used to treat schizophrenia and severe behavioral problems. They help manage symptoms in patients under medical supervision.

Why This Is Dangerous

The contamination with N-Nitroso Desmethyl Chlorpromazine poses serious health risks, including potential carcinogenic effects if consumed. Those affected should take immediate action to discontinue use.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Affected consumers may face health risks and financial burden from returning and replacing medications, stressing the need for careful medical supervision.

Practical Guidance

How to identify if yours is affected

Check lot numbers against the recall list: Z403011 or Z407335.
Verify the expiration dates: 30-04-26 or 30-11-26.
Contact your healthcare provider for confirmation if uncertain.

Where to find product info

Look for the lot number and expiration date on the label of the bottle or packaging of the tablets.

What timeline to expect

Expect about 4-6 weeks for refund processing after you return the recalled product.

If the manufacturer is unresponsive

Document your communications with Zydus Pharmaceuticals for future reference.
Consider contacting consumer protection agencies if responses are slow.

How to prevent similar issues

Always consult healthcare providers before starting new medications.
Check for recent recalls on medications before use.
Be aware of the signs of contamination, such as unexpected changes in medication appearance.

Documentation advice

Keep a copy of your purchase receipt, any communications with the manufacturer, and photographs of the product for your records.

Product Details

Brand: Zydus Lifesciences Product: Chlorpromazine Hydrochloride Tablets, USP, 10 mg Count: 100-count bottle NDC: 16714-047-01 Manufacturer Location: Baddi, India Distributed by: Northstar Rx LLC, Memphis, TN

Reported Incidents

No injuries or incidents have been reported.

Key Facts

NDC: 16714-047-01
10 mg dosage, 100-count bottle
Contaminated with N-Nitroso Desmethyl Chlorpromazine
Distributed nationwide in the USA
Stop using and consult healthcare provider

View Original Recall on FDA - Drug Safety

Browse More Recalls

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Drugs & Medications

Product TypeChlorpromazine Hydrochloride Tablets

Product Details

Brands

Zydus Lifesciences Northstar Rx LLC

Related Recalls

Health & Personal Care

HIGH

Viona Pharmaceuticals Recalls 13,080 Tavaborole Topical Solution 5% Bottles (2025 Recall)

Viona Pharmaceuticals recalled 13,080 Tavaborole Topical Solution 5%, 10 mL bottles distributed nationwide in the United States. The recall covers Tavaborole Topical Solution 5%, Rx only, manufactured by Zydus Lifesciences Ltd. Discoloration linked to RES #97424 prompted the action. Consumers should stop using the product and contact Viona for guidance.

Oct 6, 2025

Zydus Lifesciences

Discoloration -

Health & Personal Care

HIGH

Zydus Chlorpromazine Hydrochloride 200 mg Recall Expands Nationwide Over CGMP Deviations

The FDA confirms a nationwide recall of Zydus Lifesciences Chlorpromazine Hydrochloride tablets 200 mg (NDC 70710-1133-1) distributed by Zydus Pharmaceuticals USA. The recall cites CGMP deviations and the presence of N-Nitroso Desmethyl Chlorpromazine above acceptable intake. Consumers and healthcare providers should stop using the product immediately and contact the distributor for guidance.

Sep 3, 2025

Chlorpromazine Hydrochloride

CGMP Deviations:

Health & Personal Care

HIGH

Zydus Lifesciences Chlorpromazine Hydrochloride 100 mg Recall 2025

Zydus Lifesciences Ltd. and Zydus Pharmaceuticals (USA) Inc. recall Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottles distributed nationwide in the United States. The recall stems from CGMP deviations that allowed N-Nitroso Desmethyl Chlorpromazine to exceed the acceptable intake limit. Health care providers and patients should stop using the product and contact the manufacturer

Sep 3, 2025

Zydus Lifesciences

CGMP Deviations:

Health & Personal Care

HIGH

Zydus Lifesciences Chlorpromazine Tablets Recalled for N-Nitroso Desmethyl Chlorpromazine Beyond FDA

Chlorpromazine Hydrochloride Tablets, 200 mg, 100-count bottle, manufactured by Zydus Lifesciences Ltd. and distributed by Northstar Rx LLC, are under recall nationwide in the United States. The CGMP deviation involves elevated levels of N-Nitroso Desmethyl Chlorpromazine. Consumers should stop use and contact their healthcare provider.

Sep 3, 2025

Zydus Lifesciences

CGMP Deviations:

Health & Personal Care

HIGH

Zydus Lifesciences Chlorpromazine Hydrochloride Tablets Recall 100-Count Bottles (2025)

Zydus Lifesciences Ltd. recalled chlorpromazine hydrochloride tablets nationwide in the United States after tests found N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit. The issue involves CGMP deviations in manufacturing at the India facility and distribution by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ. Healthcare providers and patients should stop using the product, 0

Sep 3, 2025

Zydus Lifesciences

CGMP Deviations:

Health & Personal Care

HIGH

Zydus Lifesciences Chlorpromazine Hydrochloride Tablets 50 mg 100-count Recall 2025

Zydus Lifesciences and Northstar Rx LLC recall Chlorpromazine Hydrochloride Tablets, 50 mg, 100-count bottles distributed nationwide in the United States. The recall cites CGMP deviations and the presence of N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit. Stop using the product immediately and contact your healthcare provider or Zydus Pharmaceuticals (USA) Inc for guidance.

Sep 3, 2025

Zydus Lifesciences

CGMP Deviations:

Health & Personal Care

HIGH

Zydus Lifesciences Chlorpromazine Hydrochloride Tablets 25 mg 100-count Recall 2025

Zydus Lifesciences and Northstar Rx LLC recall Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottles nationwide in the United States. The recall cites CGMP deviations and the presence of N-nitroso desmethyl chlorpromazine above acceptable intake limits. Consumers should stop using the product and contact the manufacturer or a healthcare provider for guidance.

Sep 3, 2025

Zydus Lifesciences

CGMP Deviations:

Health & Personal Care

HIGH

Zydus Lifesciences Chlorpromazine Hydrochloride 100 mg Recall 2025

Zydus Lifesciences Chlorpromazine Hydrochloride Tablets, 100 mg, 100-count bottles distributed nationwide in the USA for Northstar Rx LLC, Memphis, TN 38141, are recalled. The recall cites CGMP deviations with the presence of N-Nitroso Desmethyl Chlorpromazine above the acceptable intake. Healthcare providers and patients should stop using the product immediately and contact the manufacturer or a医

Sep 3, 2025

Zydus Lifesciences

CGMP Deviations: