HIGH

Major Pharmaceuticals Chlorpromazine Hydrochloride 200 mg Recall Involves 1,394 Blister Packs (2025)

Major Pharmaceuticals recalled 1,394 blister packs of Chlorpromazine Hydrochloride Tablets, 200 mg, distributed nationwide. The recall cites CGMP deviations with the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit. Healthcare providers and patients are urged to stop using the product and await guidance from Major Pharmaceuticals and Rugby Laboratories.

Quick Facts at a Glance

Recall Date
September 12, 2025
Hazard Level
HIGH
Brands
Chlorpromazine Hydrochloride, Major Pharmaceuticals
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 prescribed for certain psychiatric conditions. The recalled tablets were distributed nationwide in blister packs across the United States.

Why This Is Dangerous

The recall centers on CGMP deviations due to the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit detected in the product.

Industry Context

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

Real-World Impact

Patients prescribed this drug may be affected if they possess the recalled lots. The immediate action is to stop use and contact the sponsor for guidance.

Practical Guidance

How to identify if yours is affected

  1. Check packaging for NDC 0904-7133-61
  2. Look for the batch or lot number on the blister pack
  3. Verify the product is Chlorpromazine Hydrochloride Tablets, 200 mg, 100-tablet blister packs

Where to find product info

NDC 0904-7133-61 and UPC 0100309047133611 on the package

What timeline to expect

Refunds or replacements are handled per sponsor recall communications, typically within weeks to a few months following confirmation

If the manufacturer is unresponsive

  • Document all communications with the sponsor
  • File a consumer complaint with FDA if the sponsor is unresponsive
  • Consult a healthcare provider for alternative treatment recommendations

How to prevent similar issues

  • Verify NDC numbers before refilling or accepting medications from distributors
  • Ask pharmacists to confirm CGMP-compliant manufacturing practices
  • Monitor FDA recall updates for any changes to status

Documentation advice

Keep the recall notice, product packaging, and any correspondence with the sponsor. Record dates of purchase and prescription details if available.

Product Details

Model numbers: N01928, N02008, N02071. Where sold: Nationwide. When sold: Unknown. Price: Unknown. NDC: 0904-7133-61. UPC: 0100309047133611. Quantity recalled: 1,394 blister packs.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 1394 blister packs recalled nationwide
  • NDC 0904-7133-61 identified on product
  • N-Nitroso Desmethyl Chlorpromazine impurity above intake limit
  • Rx Only, Major Pharmaceuticals distributed via Harvard Drug Group
  • Recall status: ACTIVE as of 2025-10-15
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
POISONING

Product Classification

Product TypeChlorpromazine Hydrochloride Tablets
Sold At
Unknown

Product Details

Model Numbers
N01928
N02008
N02071
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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