Quick Facts at a Glance
- Recall Date
- September 3, 2025
- Hazard Level
- HIGH
- Brands
- Chlorpromazine Hydrochloride, Zydus Pharmaceuticals, Zydus Lifesciences
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, ELDERLY
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
- Chlorpromazine Hydrochloride, Zydus Pharmaceuticals, Zydus Lifesciences
- Product type
- Chlorpromazine Hydrochloride Tablets (200 mg)
- Model numbers
- Z305083, Z305084, Z305468, Z305469, Z305470, Z401163, Z401165, Z402217 +4 more
- UPC codes
- 70710-1129, 70710-1130, 70710-1131, 70710-1132, 70710-1133, 70710-1129-1, 70710-1129-2, 70710-1129-4 +7 more
- Sizes
- 200 mg
- 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 hydrochloride is an antipsychotic medication used to treat manic depression and schizophrenia symptoms.
Why This Is Dangerous
The impurity N-Nitroso Desmethyl Chlorpromazine above acceptable intake could pose health risks; CGMP deviations indicate manufacturing quality concerns.
Industry Context
This recall is not part of a broader pattern in the industry.
Real-World Impact
No injuries reported yet. The recall focuses on product safety and potential long-term health risks.
Practical Guidance
How to identify if yours is affected
- Verify NDC 70710-1133-1 on the bottle
- Check lot numbers if provided
- Confirm packaging shows Zydus Lifesciences or Zydus Pharmaceuticals logos
Where to find product info
FDA recall page and manufacturer contact; packaging details on label
What timeline to expect
No timeline provided; monitor FDA updates
If the manufacturer is unresponsive
- Document all contact attempts
- File a consumer complaint with FDA MedWatch if supplier unresponsive
- Consult healthcare provider for alternatives
How to prevent similar issues
- Verify NDC before dispensing to patients
- Follow CGMP compliance updates for suppliers
- Ask for documentation of manufacturing standards when sourcing drugs
Documentation advice
Keep bottle, packaging, recall notice, and correspondence with supplier
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Product Details
Brand: Chlorpromazine Hydrochloride. Manufacturer: Zydus Lifesciences Ltd., Baddi, India. Distributor: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1133-1. Quantity and packaging: 100-count bottle. Sold nationwide in the USA. Recall date: 2025-09-03. Status: Active.
Reported Incidents
No specific consumer injuries or incidents are reported in the notice.
Key Facts
- Manufactured by Zydus Lifesciences Ltd. (Baddi, India)
- Distributed by Zydus Pharmaceuticals (USA) Inc. (Pennington, NJ)
- Class II recall
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Safety Guide
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