HIGH

873 Cartons of Chlorpromazine Hydrochloride Tablets Recalled Due to Foreign Substance Risk

American Health Packaging recalled 873 cartons of Chlorpromazine Hydrochloride Tablets, USP, 200 mg, after foreign substances were detected in product packaging. A specific lot of auxiliary polyester coil contained a micro-organism, posing a high health risk. Consumers should stop using the product immediately and contact their healthcare provider for guidance.

Quick Facts at a Glance

Recall Date
August 27, 2025
Hazard Level
HIGH
Brands
Chlorpromazine Hydrochloride, American Health Packaging
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 at the manufacturing site, 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 Amerisource Health Services 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 various mental health conditions. Consumers buy it for its effectiveness in managing symptoms of schizophrenia and other disorders.

Why This Is Dangerous

The recall was issued due to a foreign substance found in the packaging material, specifically a micro-organism in the auxiliary polyester coil used for packaging. This poses a health risk, although no contamination was found on the tablets themselves.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may face inconvenience as they must stop using the product and seek alternatives while awaiting guidance for a return.

Practical Guidance

How to identify if yours is affected

  1. Check the packaging for lot numbers: 1021640 or 1022639.
  2. Identify if you've purchased Chlorpromazine Hydrochloride Tablets, USP, 200 mg.
  3. Review any correspondence from your healthcare provider regarding this recall.

Where to find product info

Look for the lot numbers on the back of the carton or blister packs of the medication.

What timeline to expect

Expect a refund or guidance within 4-6 weeks from contacting Amerisource Health Services.

If the manufacturer is unresponsive

  • Contact the FDA for reporting issues or lack of response from the manufacturer.
  • Document all communication attempts for your records.
  • Consider seeking legal advice if no resolution is reached.

How to prevent similar issues

  • Verify packaging integrity before purchasing medications in the future.
  • Check for any recalls regularly on the FDA website.
  • Ensure medications are sourced from reputable pharmacies.

Documentation advice

Keep all receipts, correspondence, and photos of the product as documentation for your refund process.

Product Details

Product: Chlorpromazine Hydrochloride Tablets, USP, 200 mg NDC: 60687-463-01 Distributed by: American Health Packaging, Columbus, Ohio Quantity Recalled: 873 cartons Model Numbers: Lot: 1021640, Lot: 1022639

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 873 cartons recalled nationwide
  • Associated with Chlorpromazine Hydrochloride Tablets, USP, 200 mg
  • Packaging found to contain foreign substance
  • Lot numbers: 1021640, 1022639
  • Contact Amerisource Health Services for guidance

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
GENERAL
Injury Types
OTHER

Product Classification

Product TypeChlorpromazine Hydrochloride Tablets
Sold At
Multiple Retailers

Product Details

Model Numbers
Lot: 1021640
Lot: 1022639
UPC Codes
60687-419
60687-430
60687-441
+12 more
Affected States
ALL
Report Date
September 24, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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