HIGH

Major Pharmaceuticals Chlorpromazine 25 mg Tablets Recalled for Nitrosamine Contamination (1256 Bls,

Major Pharmaceuticals recalled 1,256 blister packs of Chlorpromazine Hydrochloride tablets, 25 mg, sold nationwide in the United States. A CGMP deviation led to the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake. Healthcare providers and patients should stop using the product and contact Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories for next-步

Quick Facts at a Glance

Recall Date
September 12, 2025
Hazard Level
HIGH
Brands
Chlorpromazine Hydrochloride, Major Pharmaceuticals
Category
Health & Personal Care
Sold At
Multiple Retailers
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 used to treat certain mental health conditions. This recall pertains to a specific batch of 25 mg tablets packaged as 100 per blister.

Why This Is Dangerous

Nitrosamines are potential carcinogens. The recall cites CGMP deviations that allowed N-Nitroso Desmethyl Chlorpromazine above the recommended intake.

Industry Context

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

Real-World Impact

Patients taking this medication should stop using it and consult their healthcare provider. The recall could prompt changes in medication regimens and require medical supervision.

Practical Guidance

How to identify if yours is affected

  1. Check NDC 0904-7130-61 on the bottle label
  2. Check UPC 01 00309047130610 on the packaging
  3. Look for model numbers N01954 or N02024
  4. Confirm packaging: 100 tablets per blister, 10x10 blister packs
  5. If a match is found, stop using the product immediately

Where to find product info

FDA recall page linked above and recall letters from Major Pharmaceuticals and Rugby Laboratories

What timeline to expect

Refunds or replacements typically processed after recall verification; estimate 4-8 weeks

If the manufacturer is unresponsive

  • Document all attempts to contact the company
  • File a complaint with the FDA if the company does not respond

How to prevent similar issues

  • Verify NDC numbers before dispensing medications
  • Ask clinicians to verify batch information before prescribing
  • Monitor FDA recall notices for drug safety alerts

Documentation advice

Keep the recall letter, packaging photographs, receipts, and all communications with healthcare providers or pharmacies

Product Details

Model numbers: N01954, N02024. Sold nationwide in blister packs containing 100 tablets (10x10) per pack. NDC 0904-7130-61. UPC 01 00309047130610. Pack size: 1256 blister packs. Category: Prescription drug. Sold by The Harvard Drug Group LLC dba Major Pharmaceuticals; distributed in the United States.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 1,256 blister packs recalled
  • NDC 0904-7130-61
  • UPC 01 00309047130610
  • Model numbers N01954 and N02024
  • Packaging: 100 tablets per blister, 10x10
  • Recall status: ACTIVE
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, 25 mg
Sold At
Multiple Retailers

Product Details

Model Numbers
N01954
N02024
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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