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, 100 mg
- Model numbers
- Z305456, Z401156, Z407306
- 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 is an antipsychotic used to treat schizophrenia and other psychiatric conditions. It is a prescription medication in the United States. The recalled product was manufactured in India for Northstar Rx LLC.
Why This Is Dangerous
The hazard arises from CGMP deviations leading to nitrosamine impurity exposure. Nitrosamines have been linked to cancer risk with long-term exposure.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
If exposed to the impurity, patients may face potential cancer risk. Immediate cessation of use is advised and medical guidance should be sought.
Practical Guidance
How to identify if yours is affected
- Check NDC 16714-050-01 on the bottle label.
- Inspect lot numbers Z305456, Z401156, Z407306 on the bottle.
- Confirm distribution by Northstar Rx LLC nationwide in the USA.
Where to find product info
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0637-2025
What timeline to expect
Not specified in the recall notice.
If the manufacturer is unresponsive
- Escalate to FDA MedWatch or your clinician for guidance.
- Consider filing a recall report with the FDA.
How to prevent similar issues
- Verify NDC numbers before obtaining prescribed medications.
- Consult your healthcare provider before switching or stopping a prescribed drug.
- Use medications from verified manufacturers and pharmacies.
Documentation advice
Keep the recall notice, bottle label, NDC, and lot numbers. Document communications with healthcare providers and manufacturers.
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Product Details
Product: Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle (Rx only). Manufacturer: Zydus Lifesciences Ltd., Baddi, India. Manufactured for: Northstar Rx LLC, Memphis, TN 38141. NDC: 16714-050-01. Lot numbers: Z305456; Z401156; Z407306. Sold nationwide in the USA. Recall date: 2025-09-03. Status: Active. Hazard level: HIGH. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Lot numbers Z305456, Z401156, Z407306
- Manufactured in India for Northstar Rx LLC
- Distributed Nationwide in the USA
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Safety Guide
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