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
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, 50 mg
- Model numbers
- N02009, N02026
- 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 a prescription antipsychotic used for certain psychiatric conditions. The recalled lots were packaged as 50 mg tablets in 10x10 blister packs and distributed nationwide.
Why This Is Dangerous
The impurity N-Nitroso Desmethyl Chlorpromazine was found above the recommended intake limit due to CGMP deviations in manufacturing. Prolonged exposure to nitrosamine impurities can pose health risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers prescribed this drug should stop using the affected lots and contact their healthcare provider. The recall covers 506 blister packs nationwide and may affect patients who rely on this medication for treatment.
Practical Guidance
How to identify if yours is affected
- Check NDC 0904-7131-61 on the bottle label.
- Verify model numbers N02009 or N02026 on the packaging.
- Look for 50 mg dosage in a (10x10) blister pack.
- Confirm packaging type and UPC if present.
Where to find product info
FDA enforcement page for recall D-0011-2026 and the distributor’s recall notice.
What timeline to expect
Refunds or replacements, if offered, typically take 4-8 weeks.
If the manufacturer is unresponsive
- Document all contact attempts with the distributor.
- File a complaint with the FDA or state consumer protection agency if no response is received.
- Consult your healthcare provider for interim alternatives.
How to prevent similar issues
- When buying prescription medications, verify CGMP compliance and recall status.
- Check NDC codes before use.
- Keep packaging and recall notices until resolved.
Documentation advice
Retain the product packaging, recall notice, and any correspondence with the distributor and your healthcare provider for records.
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Product Details
Model numbers: N02009, N02026. NDC: 0904-7131-61. UPC: (01)00309047131617. Quantity: 506 blister packs. Distribution: Nationwide. Sold at: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 506 blister packs recalled
- Model numbers N02009 and N02026
- Nitrosamine impurity above intake limit
- No injuries reported
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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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