Quick Facts at a Glance
- Recall Date
- September 3, 2025
- Hazard Level
- HIGH
- Brand
- Zydus Lifesciences
- 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
- Product type
- Chlorpromazine hydrochloride tablets
- Model numbers
- Z306327, Z306748, Z401154, Z403738, Z405645
- UPC codes
- 70710-1129, 70710-1130, 70710-1131, 70710-1132, 70710-1133, 70710-1129-1, 70710-1129-2, 70710-1129-4 +7 more
- Sizes
- 50 mg, 100-count bottle
- 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 medication used to treat certain psychiatric conditions. It is distributed as Rx-only tablets and requires medical supervision.
Why This Is Dangerous
The recall centers on CGMP deviations that led to the detection of an impurity, N-Nitroso Desmethyl Chlorpromazine, above acceptable intake limits. Consumers should stop use immediately unless advised otherwise by a healthcare provider.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Patients with the affected product may be exposed to higher impurity levels. There is an immediate safety concern, and providers should assess alternatives as needed.
Practical Guidance
How to identify if yours is affected
- Identify the bottle by the NDC 70710-1131-1.
- Check model numbers on the bottle or packaging: Z306327, Z306748, Z401154, Z403738, Z405645.
- If in doubt, contact the distributor for confirmation
Where to find product info
NDC is printed on the bottle label; packaging and Rx labels list the model numbers and lot codes.
What timeline to expect
The recall notice does not specify a refund or replacement timeline.
If the manufacturer is unresponsive
- File a complaint with FDA if the company is unresponsive
- Consult your healthcare provider for guidance on alternatives
How to prevent similar issues
- Always verify NDC and model numbers before using Rx drugs
- Consult a pharmacist or physician before switching medications
- Stay informed via official FDA recall notices
Documentation advice
Keep the recall notice, bottle label, and any correspondence with the manufacturer or healthcare providers. Photograph the label and store a digital copy of the notice.
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Product Details
Model numbers: Z306327, Z306748, Z401154, Z403738, Z405645. NDC: 70710-1131-1. Sold nationwide in the USA. Manufactured by Zydus Lifesciences Ltd., Baddi, India. Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. Rx only. Price: Unknown. Sold as 50 mg, 100-count bottles.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Nationwide distribution in the United States.
- Manufactured in Baddi, India; distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ.
- Hazard: CGMP deviations with N-Nitroso Desmethyl Chlorpromazine above acceptable limits.
- Hazard level: HIGH; no reported injuries.
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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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