HIGH

Amneal Chlorpromazine Hydrochloride 50 mg Tablets Recall 2025 (13,130 Bottles)

Amneal Pharmaceuticals recalled 13,130 bottles of CHLORPROMAZINE HYDROCHLORIDE 50 mg tablets distributed nationwide in the USA. A specific lot of auxiliary polyester coil used in packaging was found to contain a microorganism. No microorganism was detected on any tablets. Consumers and healthcare providers should stop using this product immediately and await further instructions from Amneal or a H

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, ELDERLY

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 disorders. It is prescribed by healthcare providers and distributed through pharmacies.

Why This Is Dangerous

A packaging coil used in the product’s packaging was found to contain a microorganism. The tablets themselves did not test positive for the microorganism.

Industry Context

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

Real-World Impact

Consumers must stop using affected bottles and await guidance for refunds or replacements. Patients may experience treatment interruptions if alternatives are not readily available.

Practical Guidance

How to identify if yours is affected

  1. Check the bottle label for NDC 69238-1058-1.
  2. Check the bottle lot numbers AM240147, AM240148, AM240664, AM240665.
  3. Compare against the recalled lots listed in the FDA notice.

Where to find product info

Recall details and identifiers can be found on the FDA enforcement page for D-0617-2025 and the Amneal recall notice.

What timeline to expect

Refund or replacement typically follows the recall process; consumer timelines vary, often 4-8 weeks for processing.

If the manufacturer is unresponsive

  • Document all communications with the brand or pharmacy.
  • File a complaint with CPSC or FDA if necessary.
  • Seek assistance from your healthcare provider for alternative medications.

How to prevent similar issues

  • Always check packaging integrity before use.
  • Verify NDC and lot numbers with the recall list prior to dispensing or using meds.
  • Buy medicines through licensed pharmacies and verify recall status before use.
  • Keep recall documents and contact information handy for follow-up.

Documentation advice

Keep the recall notice, bottle labels, purchase receipts, and correspondence with the manufacturer for records.

Product Details

NDC: 69238-1058-1. Product: Chlorpromazine Hydrochloride tablets, 50 mg, 100-count bottle. Sold nationwide in the USA. Manufacturer: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, India. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. Lot numbers: AM240147, AM240148, AM240664, AM240665. Quantity: 13,130 bottles. Class II recall. Date: 2025-08-18. Status: Active.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 13,130 bottles recalled
  • NDC 69238-1058-1
  • Lot numbers AM240147, AM240148, AM240664, AM240665
  • Manufacturer: Amneal Pharmaceuticals Pvt. Ltd. (India)
  • Distributor: Amneal Pharmaceuticals LLC (USA)
  • Packaged coil contamination detected; tablets unaffected by microorganism

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

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALELDERLY
Injury Types
POISONINGOTHER

Product Classification

Product Details

Model Numbers
AM240147
AM240148
AM240664
AM240665
UPC Codes
69238-1054
69238-1056
69238-1058
+7 more
Affected States
ALL
Report Date
September 10, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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