What is being recalled and why?

Chlorpromazine hydrochloride tablets manufactured by Zydus Lifesciences are being recalled nationwide in the United States due to CGMP deviations and the presence of N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit.

What is the impurity involved in this recall?

N-Nitroso Desmethyl Chlorpromazine was detected at levels above the recommended intake limit.

Who manufactured and distributed this product?

Manufactured by Zydus Lifesciences Ltd. in Baddi, India. Distributed in the USA by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ.

What products are affected?

Chlorpromazine hydrochloride tablets, 50 mg, 100-count bottles, NDC 70710-1131-1, model numbers Z306327, Z306748, Z401154, Z403738, Z405645.

Are there any injuries reported?

No injuries or incidents have been reported to date.

Where can I find more information?

The FDA recall enforcement page provides details at recall number D-0634-2025. See the link in official notices for disposal or return instructions.

Will I get a refund or replacement?

The recall notice advises stopping use and contacting the manufacturer for guidance. Specific refund or replacement details are not provided in the notice.

What is CGMP and why does it matter here?

CGMP deviations refer to manufacturing controls not meeting current good manufacturing practice standards. In this recall, such deviations were linked to the impurity above acceptable limits.

How do I identify if my bottle is affected?

Check the NDC on the bottle label (70710-1131-1) and compare the lot/model numbers against the recalled models Z306327, Z306748, Z401154, Z403738, Z405645.

HIGHSeptember 3, 2025

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

Q: What should I do if I have this product?

Stop using the product immediately and contact Zydus Pharmaceuticals (USA) Inc. or your healthcare provider for guidance. Check your bottle for the NDC and model numbers listed in the recall.

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

Quick Facts at a Glance

Recall Date: September 3, 2025
Hazard Level: HIGH
Brand: Zydus Lifesciences
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 is an antipsychotic medication used to treat certain psychiatric conditions. It is distributed as Rx-only tablets and requires medical supervision.

Why This Is Dangerous

The recall centers on CGMP deviations that led to the detection of an impurity, N-Nitroso Desmethyl Chlorpromazine, above acceptable intake limits. Consumers should stop use immediately unless advised otherwise by a healthcare provider.

Industry Context

This recall is not described as part of a broader industry pattern in the notice.

Real-World Impact

Patients with the affected product may be exposed to higher impurity levels. There is an immediate safety concern, and providers should assess alternatives as needed.

Practical Guidance

How to identify if yours is affected

Identify the bottle by the NDC 70710-1131-1.
Check model numbers on the bottle or packaging: Z306327, Z306748, Z401154, Z403738, Z405645.
If in doubt, contact the distributor for confirmation

Where to find product info

NDC is printed on the bottle label; packaging and Rx labels list the model numbers and lot codes.

What timeline to expect

The recall notice does not specify a refund or replacement timeline.

If the manufacturer is unresponsive

File a complaint with FDA if the company is unresponsive
Consult your healthcare provider for guidance on alternatives

How to prevent similar issues

Always verify NDC and model numbers before using Rx drugs
Consult a pharmacist or physician before switching medications
Stay informed via official FDA recall notices

Documentation advice

Keep the recall notice, bottle label, and any correspondence with the manufacturer or healthcare providers. Photograph the label and store a digital copy of the notice.

Product Details

Model numbers: Z306327, Z306748, Z401154, Z403738, Z405645. NDC: 70710-1131-1. Sold nationwide in the USA. Manufactured by Zydus Lifesciences Ltd., Baddi, India. Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. Rx only. Price: Unknown. Sold as 50 mg, 100-count bottles.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

NDC 70710-1131-1.
Models: Z306327, Z306748, Z401154, Z403738, Z405645.
Nationwide distribution in the United States.
Manufactured in Baddi, India; distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ.
Hazard: CGMP deviations with N-Nitroso Desmethyl Chlorpromazine above acceptable limits.
Hazard level: HIGH; no reported injuries.

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

POISONING

Product Classification

CategoryHealth & Personal Care › Drugs & Medications

Product TypeChlorpromazine hydrochloride tablets

Product Details

Brand

Zydus Lifesciences

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 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 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 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.

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: