HIGH

Chlorpromazine Hydrochloride 200 mg Recall Expanded After Packaging Contamination Found in 3,363 JDS

Amneal Pharmaceuticals products containing chlorpromazine hydrochloride are recalled nationwide after the FDA-linked notice identifies a foreign substance in packaging material. No tablets were contaminated. The recall was issued August 18, 2025 and updated September 10, 2025. Consumers and healthcare providers should stop using the affected lots immediately and contact Amneal 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
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, PETS

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 is an antipsychotic medication used to treat certain psychiatric conditions. It is only available by prescription.

Why This Is Dangerous

A foreign substance in packaging, specifically a polyester coil, was detected with a microorganism. No contamination found in the tablets themselves.

Industry Context

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

Real-World Impact

Consumers must stop using affected bottles. Healthcare providers should review patient safety and determine next steps.

Practical Guidance

How to identify if yours is affected

  1. Check bottle label for Chlorpromazine Hydrochloride 200 mg
  2. Verify NDC 69238-1062-1
  3. Inspect lot AM240336 or AM240337
  4. Check expiration date 02/28/2027
  5. Confirm bottle size: 100-count

Where to find product info

Recall notice letters and FDA recall page D-0619-2025

What timeline to expect

Refunds or replacements will be issued per recall letters, typically within weeks to a couple of months

If the manufacturer is unresponsive

  • Document all attempts to contact the company
  • File a report with CPSC or FDA if company is slow to respond
  • Consult your pharmacist or physician for interim safety steps

How to prevent similar issues

  • Verify packaging integrity before purchase
  • Watch for packaging defects in future drug purchases
  • Only obtain prescriptions through licensed pharmacies
  • Keep a copy of the recall notice and patient safety information

Documentation advice

Keep copy of recall letters, receipts, and correspondence with manufacturer or pharmacy

Product Details

Product: Chlorpromazine Hydrochloride Tablets, USP 200 mg, 100-count bottles. Manufacturer: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, India. Distributor: Amneal Pharmaceuticals LLC, Bridgewater, NJ. Distribution: Nationwide in the USA. NDC: 69238-1062-1. Lot numbers: AM240336, AM240337. Expiration: 02/28/2027. Quantity: 3,363 bottles.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 3,363 bottles recalled
  • Lot AM240336 and AM240337
  • Exp 02/28/2027
  • NDC 69238-1062-1
  • Package material contamination not found in tablets
  • Active recall status as of 2025-09-10

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
GENERALPREGNANTPETS
Injury Types
POISONINGELECTRICALLACERATIONOTHER

Product Details

Model Numbers
Lot AM240336
Lot AM240337
Exp 02/28/2027
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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