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
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
- Major Pharmaceuticals, Chlorpromazine Hydrochloride
- Product type
- Chlorpromazine Hydrochloride Tablets
- Model numbers
- N01943, N02025
- 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
- Unknown
- 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 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
- Verify packaging: 50 tablets per blister pack in a 5x10 arrangement.
- Check NDC 0904-7130-06 on the label.
- 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.
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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
- 50 tablets per blister pack (5x10)
- Distributed nationwide by Major Pharmaceuticals
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Safety Guide
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