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
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT
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
- Z305085, Z401166, Z401167
- 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
- Unknown
- 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 is an antipsychotic used to treat schizophrenia and bipolar disorder. It is a prescription medication distributed nationwide in the United States.
Why This Is Dangerous
N-Nitroso Desmethyl Chlorpromazine above acceptable intake limits can raise health concerns with long-term exposure.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
No injuries reported in the recall. Consumers should stop use and seek guidance from healthcare providers.
Practical Guidance
How to identify if yours is affected
- Identify NDC 16714-051-01 on bottle label
- Verify lot numbers on packaging if available
- Check FDA recall notice for affected lots
Where to find product info
NDC label, pharmacy packaging, and FDA recall page
What timeline to expect
Remedy process and refunds/replacements typically guided by manufacturer and FDA timelines
If the manufacturer is unresponsive
- Document all contacts and responses
- Escalate to FDA recall hotline if needed
- Consider legal counsel if unaddressed for serious health concerns
How to prevent similar issues
- Verify NDC and lot numbers when receiving prescription medications
- Ask pharmacists about CGMP compliance and lot-specific recalls
- Check FDA recall database routinely
Documentation advice
Retain recall notices, prescription records, and all correspondence with manufacturers and pharmacies
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Product Details
Brand: Zydus Lifesciences; Distributor: Northstar Rx LLC; Product: Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle; NDC: 16714-051-01; Manufactured by: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC, Memphis, TN 38141; Sold nationwide in the USA; Status: Active recall as of 2025-09-03; Models: Z305085, Z401166, Z401167.
Reported Incidents
No specific injuries or incidents are detailed in the recall notice.
Key Facts
- Manufactured for Northstar Rx LLC, Memphis, TN 38141
- Active recall date: 2025-09-03
- Model numbers: Z305085, Z401166, Z401167
- CGMP deviations: elevated N-Nitroso Desmethyl Chlorpromazine
- Nationwide distribution in the USA
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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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