Is it safe to take these tablets if I already have them at home?

No. The recall is due to packaging contamination potential. Do not use the product and consult your healthcare provider for guidance on alternatives.

How can I identify if my bottle is part of the recall?

Check the NDC 69238-1060-1 and the lot numbers AM240334, AM240335, or AM241031 on the bottle or packaging. If you have any, stop using it and contact your supplier.

Will I get a refund or replacement?

Refund or replacement guidance is described in the recall notice. Contact Amneal Pharmaceuticals, LLC for instructions.

Where can I find the official recall notice?

The FDA enforcement page for recall D-0618-2025 provides official details.

Who should I contact for questions about my prescription?

Reach out to your healthcare provider or pharmacist and to Amneal Pharmaceuticals, LLC for recall-specific guidance.

What should I do with the product I already purchased?

Do not consume the tablets. Keep the product with the packaging until instructed otherwise by the recall notice.

Are other Amneal products affected?

This notice specifically covers Chlorpromazine Hydrochloride tablets with the listed lot numbers. Other Amneal products are not indicated in this recall.

Could this affect patients who take this drug long-term?

If you are prescribed this medication and have concerns, contact your healthcare provider for safe alternatives.

How will the recall impact ongoing treatments?

Healthcare providers will guide replacements or adjustments as appropriate.

What is the risk if someone else in the household handles the bottle?

The recall relates to packaging material; avoid handling if you own a potentially affected bottle and follow recall guidance.

HIGHAugust 18, 2025

Amneal Chlorpromazine Hydrochloride Recall 2025: 14,923 Bottles Over Packaging Contamination

Amneal Pharmaceuticals recalled 14,923 bottles of Chlorpromazine Hydrochloride 100 mg tablets sold nationwide in the United States. A packaging coil used in the product’s packaging was found to contain a microorganism. No microorganism was detected on any tablets. Stop using the product and contact Amneal or your healthcare provider for guidance.

Quick Facts at a Glance

Recall Date: August 18, 2025
Hazard Level: HIGH
Brands: Chlorpromazine Hydrochloride, Amneal Pharmaceuticals
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 1 states
At-Risk Groups: GENERAL

Hazard Information

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Amneal Pharmaceuticals, LLC or your healthcare provider for guidance. Notification method: Letter

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 in the United States through a network of healthcare providers.

Why This Is Dangerous

A foreign microorganism was detected in packaging components made from auxiliary polyester coil. Tablets themselves were not shown to be contaminated. The risk comes from potential exposure to packaging-related contaminants.

Industry Context

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

Real-World Impact

Consumers may need to switch medications under supervision. There is no reported contamination of tablets, but packaging contamination could pose health risks.

Practical Guidance

How to identify if yours is affected

Check if your bottle bears NDC 69238-1060-1.
Look for lot numbers AM240334, AM240335, AM241031 on the bottle/box.
Confirm packaging uses auxiliary polyester coil as described in the recall.

Where to find product info

NDC and lot codes on label; recall notice provides official details.

What timeline to expect

Recall processing timelines are not specified in the notice.

If the manufacturer is unresponsive

Document all communications with the company and healthcare provider.
Escalate to FDA recall contacts if no response is received within a reasonable timeframe.
Consider filing a report with the FDA if you suspect unsafe conditions.

How to prevent similar issues

If purchasing prescription meds, verify packaging quality and lot numbers.
Consult your healthcare provider for approved alternatives if you must switch meds.
Maintain a record of recall notices and medication changes.

Documentation advice

Keep bottle, packaging, and recall notices. Save correspondence with the company and healthcare providers.

Product Details

NDC: 69238-1060-1. Sold nationwide in the USA. 14,923 bottles recalled. Lot numbers AM240334, AM240335, AM241031. 100 mg tablets in 100-count bottles. Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, India. Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. Classification: Class II. Product type: Oral solid dosage unit (Tablets).

Reported Incidents

No injuries or incidents have been reported.

Key Facts

14,923 bottles recalled nationwide
Lot numbers AM240334, AM240335, AM241031
NDC 69238-1060-1
Manufactured in India; distributed by US-based affiliate

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

7/ 10

Affected Groups

GENERAL

Injury Types

POISONING

Product Classification

CategoryHealth & Personal Care › Drugs & Medications

Product TypeChlorpromazine Hydrochloride Tablets

Product Details

Brands

Chlorpromazine Hydrochloride Amneal Pharmaceuticals

Related Recalls

Health & Personal Care

HIGH

Major Pharmaceuticals Chlorpromazine Hydrochloride 100 mg Recall 2025 — 866 Blister Packs Nationwide

Major Pharmaceuticals recalled 866 Chlorpromazine Hydrochloride 100 mg tablets distributed nationwide after CGMP deviations allowed N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit. The impurity detected raises safety concerns for ongoing use. Stop using the product immediately and contact Harvard Drug Group LLC dba Major Pharmaceuticals or Rugby Laboratories for guidance and,

Sep 12, 2025

Major Pharmaceuticals

CGMP Deviations:

Health & Personal Care

HIGH

Major Pharmaceuticals Chlorpromazine 25 mg Tablets Recalled for Nitrosamine Contamination (1256 Bls,

Major Pharmaceuticals recalled 1,256 blister packs of Chlorpromazine Hydrochloride tablets, 25 mg, sold nationwide in the United States. A CGMP deviation led to the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake. Healthcare providers and patients should stop using the product and contact Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories for next-步

Sep 12, 2025

Chlorpromazine Hydrochloride

CGMP Deviations:

Health & Personal Care

HIGH

Major Pharmaceuticals Chlorpromazine Hydrochloride 50 mg Tablets Recalled for Nitrosamine Impurity (

Major Pharmaceuticals, via The Harvard Drug Group LLC, recalled 506 blister packs of Chlorpromazine Hydrochloride tablets, 50 mg, distributed nationwide. A CGMP deviation shows the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit. Stop using the product and contact the Harvard Drug Group or Rugby Laboratories for guidance.

Sep 12, 2025

Major Pharmaceuticals

CGMP Deviations:

Health & Personal Care

HIGH

Major Pharmaceuticals Chlorpromazine Hydrochloride 25 mg Tablets Recall 2025 for CGMP Deviations

Major Pharmaceuticals recalled 2,064 blister packs of Chlorpromazine Hydrochloride Tablets, 25 mg, sold nationwide through healthcare providers. The recall follows CGMP deviations that allowed the presence of N-Nitroso Desmethyl Chlorpromazine above the allowed limit. Stop using the product immediately and await guidance from Major Pharmaceuticals or your healthcare provider.

Sep 12, 2025

Major Pharmaceuticals

CGMP Deviations:

Health & Personal Care

HIGH

Major Pharmaceuticals Chlorpromazine Hydrochloride 200 mg Recall Involves 1,394 Blister Packs (2025)

Major Pharmaceuticals recalled 1,394 blister packs of Chlorpromazine Hydrochloride Tablets, 200 mg, distributed nationwide. The recall cites CGMP deviations with the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit. Healthcare providers and patients are urged to stop using the product and await guidance from Major Pharmaceuticals and Rugby Laboratories.

Sep 12, 2025

Chlorpromazine Hydrochloride

CGMP Deviations:

Health & Personal Care

HIGH

Zydus Chlorpromazine Hydrochloride 10 mg Tablets Recalled for Nitrosamine Impurity (2025)

Zydus Lifesciences and Zydus Pharmaceuticals US recall Chlorpromazine Hydrochloride Tablets, 10 mg, 100-count bottles sold nationwide in the United States after detecting an impurity above acceptable intake. The impurity is N-Nitroso Desmethyl Chlorpromazine. Consumers should stop using the product immediately and contact the manufacturer for guidance.

Sep 3, 2025

Chlorpromazine Hydrochloride

CGMP Deviations:

Health & Personal Care

HIGH

Zydus Lifesciences Chlorpromazine Hydrochloride 25 mg 100-count Tablets Recalled Nationwide (2025)

Zydus Lifesciences Ltd. recalled Chlorpromazine Hydrochloride tablets, 25 mg, 100-count bottles distributed nationwide by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. The recall cites CGMP deviations and the presence of N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit. Stop using the product and contact your healthcare provider or Zydus Pharmaceuticals (USA) Inc. for

Sep 3, 2025

Chlorpromazine Hydrochloride

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: