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
- Model numbers
- Lot#: Z403011, Exp Date 30-04-26, Z407335, Exp Date 30-11-26
- 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 used to treat schizophrenia and severe behavioral problems. They help manage symptoms in patients under medical supervision.
Why This Is Dangerous
The contamination with N-Nitroso Desmethyl Chlorpromazine poses serious health risks, including potential carcinogenic effects if consumed. Those affected should take immediate action to discontinue use.
Industry Context
This recall is not part of a broader industry pattern.
Practical Guidance
How to identify if yours is affected
- Check lot numbers against the recall list: Z403011 or Z407335.
- Verify the expiration dates: 30-04-26 or 30-11-26.
- Contact your healthcare provider for confirmation if uncertain.
Where to find product info
Look for the lot number and expiration date on the label of the bottle or packaging of the tablets.
What timeline to expect
Expect about 4-6 weeks for refund processing after you return the recalled product.
If the manufacturer is unresponsive
- Document your communications with Zydus Pharmaceuticals for future reference.
- Consider contacting consumer protection agencies if responses are slow.
How to prevent similar issues
- Always consult healthcare providers before starting new medications.
- Check for recent recalls on medications before use.
- Be aware of the signs of contamination, such as unexpected changes in medication appearance.
Documentation advice
Keep a copy of your purchase receipt, any communications with the manufacturer, and photographs of the product for your records.
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Product Details
Brand: Zydus Lifesciences Product: Chlorpromazine Hydrochloride Tablets, USP, 10 mg Count: 100-count bottle NDC: 16714-047-01 Manufacturer Location: Baddi, India Distributed by: Northstar Rx LLC, Memphis, TN
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 10 mg dosage, 100-count bottle
- Contaminated with N-Nitroso Desmethyl Chlorpromazine
- Distributed nationwide in the USA
- Stop using and consult healthcare provider
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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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