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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Chlorpromazine Hydrochloride, Major Pharmaceuticals
- Product type
- Chlorpromazine Hydrochloride Tablets, 25 mg
- Model numbers
- N01954, N02024
- UPC codes
- 0904-7129, 0904-7130, 0904-7131, 0904-7132, 0904-7133, 0904-7129-61, 0904-7130-61, 0904-7130-06 +4 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 12, 2025
Reported by FDA DRUG
October 15, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check NDC 0904-7130-61 on the bottle label
- Check UPC 01 00309047130610 on the packaging
- Look for model numbers N01954 or N02024
- Confirm packaging: 100 tablets per blister, 10x10 blister packs
- 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
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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
- Model numbers N01954 and N02024
- Packaging: 100 tablets per blister, 10x10
- Recall status: ACTIVE
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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