HIGH

Major Pharmaceuticals Chlorpromazine Hydrochloride 100 mg Recall 2025 — 866 Blister Packs Nationwide

Major Pharmaceuticals recalled 866 Chlorpromazine Hydrochloride 100 mg tablets distributed nationwide after CGMP deviations allowed N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit. The impurity detected raises safety concerns for ongoing use. Stop using the product immediately and contact Harvard Drug Group LLC dba Major Pharmaceuticals or Rugby Laboratories for guidance and,

Quick Facts at a Glance

Recall Date
September 12, 2025
Hazard Level
HIGH
Brands
Major Pharmaceuticals, Chlorpromazine Hydrochloride
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 a prescription antipsychotic used to treat certain psychiatric conditions. The tablets are Rx-only and distributed nationwide.

Why This Is Dangerous

N-nitroso impurities are potential carcinogens. The recall cites an impurity level above the recommended intake limit, prompting cessation of use.

Industry Context

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

Real-World Impact

Patients taking the medication may be affected nationwide. Immediate action is required to stop using the product and contact providers for guidance and refunds.

Practical Guidance

How to identify if yours is affected

  1. Verify NDC 0904-7132-61 on the packaging.
  2. Check packaging for 100 mg strength and 100 tablets per blister pack (10x10).
  3. Look for model numbers N01920, N02023, or N02202 on the product or packaging.

Where to find product info

Packaging, patient information leaflets, and the FDA recall page for D-0012-2026.

What timeline to expect

Refund/replacement processing times are not specified in the recall notice.

If the manufacturer is unresponsive

  • Document all contact attempts.
  • File a complaint with the FDA if the company remains unresponsive.
  • Consult your pharmacist or physician for alternatives.

How to prevent similar issues

  • Only obtain prescriptions through licensed pharmacies.
  • Check NDC and lot numbers before consuming any medication.
  • Be vigilant for recalls on Rx medications and verify with your pharmacist regularly.

Documentation advice

Keep the recall notification, photos of packaging and labels, and records of all communications with the manufacturer or provider.

Product Details

Brand: Major Pharmaceuticals. Product: Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100 tablets. Packaging: 100 tablets per blister, 10x10 blister packs. NDC: 0904-7132-61. UPC: (01)00309047132614. Quantity recalled: 866 blister packs. Sold/distributed: Nationwide. Rx status: Rx Only. Distributor/Manufacturer: The Harvard Drug Group LLC dba Major Pharmaceuticals; Rugby Laboratories; Major Pharmaceuticals, Indianapolis, IN 46268, USA. Recall date: 2025-09-12. Status: Active. Model numbers: N01920, N02023, N02202.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 866 blister packs recalled
  • NDC 0904-7132-61
  • Model numbers N01920, N02023, N02202
  • Hazard: N-Nitroso Desmethyl Chlorpromazine impurity above intake limit
  • Recall date 2025-09-12; status Active
View Original Recall on FDA - Drug Safety

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Safety Guide

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Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
6/ 10
Affected Groups
GENERAL
Injury Types
POISONING

Product Classification

Product TypeChlorpromazine Hydrochloride Tablets, USP 100 mg
Sold At
Multiple Retailers

Product Details

Model Numbers
N01920
N02023
N02202
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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