Quick Facts at a Glance
- Recall Date
- September 3, 2025
- Hazard Level
- HIGH
- Brands
- Zydus Lifesciences, Northstar Rx LLC
- 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
- Zydus Lifesciences, Northstar Rx LLC
- Product type
- Chlorpromazine Hydrochloride Tablets 25 mg
- Model numbers
- Z305062, Z306324, Z401151, Z401152
- UPC codes
- 16714-047, 16714-048, 16714-049, 16714-050, 16714-051, 16714-047-01, 16714-048-01, 16714-049-01 +2 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 3, 2025
Reported by FDA DRUG
September 17, 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 acceptable intake limit
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: N/A
About This Product
Chlorpromazine hydrochloride tablets are an older antipsychotic medication used to treat certain psychiatric conditions. They are prescription-only and distributed through healthcare channels.
Why This Is Dangerous
The CGMP deviation allowed nitrosamine impurities at levels above acceptable intake. Nitrosamines can pose cancer risks with long-term exposure.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients may need to switch medications under clinician guidance. Stored or dispensed lots may be recalled from pharmacies.
Practical Guidance
How to identify if yours is affected
- Check the bottle label for NDC 16714-048-01
- Check for model identifiers: Z305062, Z306324, Z401151, Z401152
- Ensure the product is Chlorpromazine Hydrochloride 25 mg 100-count bottle
Where to find product info
NDC on packaging; recall notice on FDA enforcement page and manufacturer communications
What timeline to expect
Refund or replacement processing typically 4-8 weeks after submission of required information
If the manufacturer is unresponsive
- Document all contact attempts
- File a consumer safety complaint with FDA if needed
- Consult your clinician if you rely on this medication for mental health treatment
How to prevent similar issues
- Verify NDC against recall notices before dispensing
- Use trusted pharmacies
- Check CGMP compliance in manufacturing and supplier origin
Documentation advice
Keep packaging, receipts, and correspondence; photograph bottle and label for records
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Product Details
Model numbers: Z305062, Z306324, Z401151, Z401152; NDC 16714-048-01; 25 mg, 100-count RX bottles; Rx only; Manufactured by Zydus Lifesciences Ltd., Baddi, India; Manufactured for Northstar Rx LLC, Memphis, TN 38141; Distribution: Nationwide in the USA.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 4 model numbers affected: Z305062, Z306324, Z401151, Z401152
- Recall status: ACTIVE
- Hazard level: HIGH
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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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