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, USP 100 mg
- Model numbers
- N01920, N02023, N02202
- 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 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
- Verify NDC 0904-7132-61 on the packaging.
- Check packaging for 100 mg strength and 100 tablets per blister pack (10x10).
- 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.
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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
- Model numbers N01920, N02023, N02202
- Hazard: N-Nitroso Desmethyl Chlorpromazine impurity above intake limit
- Recall date 2025-09-12; status Active
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Safety Guide
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