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.

Quick Facts at a Glance

Recall Date
September 12, 2025
Hazard Level
HIGH
Brands
Major Pharmaceuticals, Chlorpromazine Hydrochloride
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories or your healthcare provider for guidance. Notification method: Letter

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About This Product

Chlorpromazine hydrochloride is an antipsychotic medication used for certain psychiatric conditions and sometimes as an antiemetic in medical settings.

Why This Is Dangerous

N-nitroso desmethyl chlorpromazine can pose health risks when present above the recommended limit due to CGMP deviations.

Industry Context

This recall is not described as part of a broader industry pattern in the provided data.

Real-World Impact

The recall affects patients and healthcare providers who rely on this medication; stopping use is advised and guidance will follow recall communications.

Practical Guidance

How to identify if yours is affected

  1. Verify packaging: 50 tablets per blister pack in a 5x10 arrangement.
  2. Check NDC 0904-7130-06 on the label.
  3. Check UPC: (01)00309047130061.
  4. Confirm blister packs total 2064 units.

Where to find product info

Recall notices and identifiers are listed in the FDA enforcement page linked in the recall notice.

What timeline to expect

Refunds or replacements, if offered, will follow the company's recall timeline communicated by letters.

If the manufacturer is unresponsive

  • Escalate to FDA recall program
  • Document all communications and dates
  • Consult your pharmacist or physician for guidance on alternatives

How to prevent similar issues

  • Verify NDC numbers before purchasing prescription meds
  • Ask your pharmacist about CGMP compliance of suppliers
  • Avoid purchasing Rx meds from unverified sources

Documentation advice

Keep the packaging, recall notices, and records of any communications with the supplier.

Product Details

Product: Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 50 tablets per blister pack (5x10). NDC: 0904-7130-06. UPC: (01)00309047130061. Quantity: 2064 blister packs. Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA. Sold nationwide to healthcare providers. Models: N01943, N02025. Recall date: 2025-09-12. Status: Active. Classification: Class II. Hazard: N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit. Remedy: Stop using the product and contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories for guidance. Country of origin: 

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 2064 blister packs recalled
  • NDC 0904-7130-06
  • UPC (01)00309047130061
  • 50 tablets per blister pack (5x10)
  • Rx Only
  • Distributed nationwide by Major Pharmaceuticals
View Original Recall on FDA - Drug Safety

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Safety Guide

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Safety Assessment

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

Product Classification

Product TypeChlorpromazine Hydrochloride Tablets
Sold At
Unknown

Product Details

Model Numbers
N01943
N02025
UPC Codes
0904-7129
0904-7130
0904-7131
+9 more
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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