Quick Facts at a Glance
- Recall Date
- September 3, 2025
- Hazard Level
- HIGH
- Brands
- Zydus Lifesciences, Zydus Pharmaceuticals
- 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, Zydus Pharmaceuticals
- Product type
- Chlorpromazine Hydrochloride Tablets
- Model numbers
- Z305079, Z305080, Z305454, Z305455, Z305457, Z400492, Z400493, Z400494 +7 more
- UPC codes
- 70710-1129, 70710-1130, 70710-1131, 70710-1132, 70710-1133, 70710-1129-1, 70710-1129-2, 70710-1129-4 +7 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 medication used to treat certain psychiatric conditions. It is distributed as a prescription drug and requires pharmacy verification.
Why This Is Dangerous
N-Nitroso Desmethyl Chlorpromazine is a nitrosamine impurity. Exposure levels above the acceptable intake limit may pose health risks over time.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Patients must stop using the affected product and seek medical guidance. The recall may require medical substitution and monitoring.
Practical Guidance
How to identify if yours is affected
- Identify the product by NDC 70710-1132-1
- Check model numbers listed in recall materials
- Confirm distributor as Zydus Pharmaceuticals (USA) Inc.
Where to find product info
NDC is printed on the bottle label. Recall pages and the FDA enforcement report provide model lists and guidance.
What timeline to expect
No refunds are specified for prescription drug recalls. Substitutions or guidance will be provided by the manufacturer and clinicians; timelines vary.
If the manufacturer is unresponsive
- File a consumer complaint with the FDA if the company is unresponsive
- Consult your clinician for safe alternatives and escalation as needed
How to prevent similar issues
- Purchase prescription meds only from licensed pharmacies
- Verify NDC and batch information before taking any drug
- Monitor for adverse effects and report to a clinician immediately
- Keep recall information for future reference
Documentation advice
Keep the product, packaging, recall notice, and any correspondence with the manufacturer or physician for records
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Product Details
Model numbers affected include Z305079, Z305080, Z305454, Z305455, Z305457, Z400492, Z400493, Z400494, Z401158, Z401725, Z401726, Z404118, Z404119, Z404120, Z405648. Sold nationwide in the USA as 100-count bottles of 100 mg chlorpromazine hydrochloride tablets. Sold as Rx only. NDC: 70710-1132-1. Manufacturer: Zydus Lifesciences Ltd. (Baddi, India). Distributed by Zydus Pharmaceuticals (USA) Inc. (Pennington, NJ 08534). Recall date: 2025-09-03.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Manufactured in India by Zydus Lifesciences
- Distributed nationwide in the USA by Zydus Pharmaceuticals (USA) Inc.
- Recall initiated 2025-09-03; status ACTIVE
- Hazard: CGMP deviations with elevated N-Nitroso Desmethyl Chlorpromazine
- No reported injuries or incidents at this time
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Safety Guide
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