Quick Facts at a Glance
- Recall Date
- September 12, 2025
- Hazard Level
- HIGH
- Brands
- Chlorpromazine Hydrochloride, Major Pharmaceuticals
- 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
- Chlorpromazine Hydrochloride, Major Pharmaceuticals
- Product type
- Chlorpromazine Hydrochloride Tablets
- Model numbers
- N01928, N02008, N02071
- 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 prescribed for certain psychiatric conditions. The recalled tablets were distributed nationwide in blister packs across the United States.
Why This Is Dangerous
The recall centers on CGMP deviations due to the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit detected in the product.
Industry Context
This recall is not described as part of a broader industry pattern in the provided notice.
Real-World Impact
Patients prescribed this drug may be affected if they possess the recalled lots. The immediate action is to stop use and contact the sponsor for guidance.
Practical Guidance
How to identify if yours is affected
- Check packaging for NDC 0904-7133-61
- Look for the batch or lot number on the blister pack
- Verify the product is Chlorpromazine Hydrochloride Tablets, 200 mg, 100-tablet blister packs
What timeline to expect
Refunds or replacements are handled per sponsor recall communications, typically within weeks to a few months following confirmation
If the manufacturer is unresponsive
- Document all communications with the sponsor
- File a consumer complaint with FDA if the sponsor is unresponsive
- Consult a healthcare provider for alternative treatment recommendations
How to prevent similar issues
- Verify NDC numbers before refilling or accepting medications from distributors
- Ask pharmacists to confirm CGMP-compliant manufacturing practices
- Monitor FDA recall updates for any changes to status
Documentation advice
Keep the recall notice, product packaging, and any correspondence with the sponsor. Record dates of purchase and prescription details if available.
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Product Details
Model numbers: N01928, N02008, N02071. Where sold: Nationwide. When sold: Unknown. Price: Unknown. NDC: 0904-7133-61. UPC: 0100309047133611. Quantity recalled: 1,394 blister packs.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 1394 blister packs recalled nationwide
- NDC 0904-7133-61 identified on product
- N-Nitroso Desmethyl Chlorpromazine impurity above intake limit
- Rx Only, Major Pharmaceuticals distributed via Harvard Drug Group
- Recall status: ACTIVE as of 2025-10-15
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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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