What is being recalled?

7,228 bottles of CHLORPROMAZINE HYDROCHLORIDE 25 mg tablets, Lot AM240617 and AM240618, NDC 69238-1056-1, are recalled due to packaging contamination.

Why is the recall being issued?

A foreign material in the packaging coil tested positive for a microorganism. No microorganisms were detected on the tablets themselves.

Who is affected by this recall?

Any consumer who has CHLORPROMAZINE HYDROCHLORIDE 25 mg tablets in Lot AM240617 or AM240618 bearing NDC 69238-1056-1.

What should I do if I have these tablets?

Stop using the product immediately and contact Amneal Pharmaceuticals LLC or your healthcare provider for guidance.

How do I find out if my bottle is affected?

Check the bottle for NDC 69238-1056-1 and Lot AM240617 or AM240618. The Expiration date is 04/30/2027.

Will I get a refund or replacement?

Refund or replacement options will be communicated by Amneal via recall notifications. Follow the instructions included in the recall letter.

Is there a risk to patients from using the tablets?

The concern is contamination risk from the packaging coil. The tablets themselves were not contaminated.

How long will process take?

Refunds or replacements are typically processed in weeks after eligibility is confirmed. Follow the recall notice for specific timelines.

What should I do with affected packaging or bottles?

Keep the bottles and recall notices until instructed to dispose or return per the recall instructions.

Where can I get more information?

Visit the FDA enforcement page for product tabs D-0616-2025 or contact Amneal Pharmaceuticals LLC.

HIGHAugust 18, 2025

Amneal Chlorpromazine Hydrochloride 25 mg 100-count Recalled in 2025 for Packaging Contamination

Amneal Pharmaceuticals LLC is recalling 7,228 bottles of CHLORPROMAZINE HYDROCHLORIDE tablets sold nationwide in the United States. Packaging coils used in the bottles tested positive for a microorganism, though no tablets were contaminated. Stop using this product immediately 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

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About This Product

Chlorpromazine hydrochloride is an antipsychotic medication used to treat certain psychiatric conditions. It is sold as prescription-only medication.

Why This Is Dangerous

A manufacturing packaging coil contained a microorganism. The tablets themselves were not contaminated, but the packaging defect raises contamination risk.

Industry Context

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

Real-World Impact

Patients with affected lots should stop using the product and await guidance. The recall covers 7,228 bottles distributed nationwide in the U.S.

Practical Guidance

How to identify if yours is affected

Verify NDC 69238-1056-1 on the bottle.
Check Lot AM240617 or AM240618.
Verify Expiration Date 04/30/2027.

Where to find product info

NDC 69238-1056-1; Lot AM240617; Lot AM240618; Exp 04/30/2027; Manufactured in India; Distributed by Amneal Pharmaceuticals LLC, NJ.

What timeline to expect

Refunds/replacements expected in 4-6 weeks after eligibility is confirmed.

If the manufacturer is unresponsive

Document all communications with Amneal.
If Amneal is unresponsive, contact the FDA or your pharmacist for guidance.

How to prevent similar issues

Only obtain prescription medications from licensed pharmacies.
Monitor recall updates from Amneal and FDA.
Discuss alternatives with your healthcare provider if needed.

Documentation advice

Keep recall letter, bottle labels, lot numbers, and any correspondence with Amneal for records.

Product Details

NDC 69238-1056-1. Lot AM240617 and Lot AM240618. Expiration date 04/30/2027. Quantity recalled: 7,228 bottles of 100-count each. Manufactured by Amneal Pharmaceuticals Pvt. Ltd. in Ahmedabad, India. Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. Sold nationwide in the U.S. Rx Only. Category: Health & Personal Care; Drugs & Medications.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

7,228 bottles recalled
Lot AM240617 and Lot AM240618 affected
Exp. date 04/30/2027
NDC 69238-1056-1
Packaging coil contamination detected
Tablets not contaminated

View Original Recall on FDA - Drug Safety

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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 25 mg, 100-count bottles (Rx Only)

Product Details

Brands

Chlorpromazine Hydrochloride Amneal Pharmaceuticals

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