Quick Facts at a Glance
- Recall Date
- September 3, 2025
- Hazard Level
- HIGH
- Brands
- Chlorpromazine Hydrochloride, 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
- Chlorpromazine Hydrochloride, Zydus Lifesciences, Zydus Pharmaceuticals
- Product type
- Chlorpromazine Hydrochloride Tablets 10 mg
- Model numbers
- Z403012, Z406657
- UPC codes
- 70710-1129, 70710-1130, 70710-1131, 70710-1132, 70710-1133, 70710-1129-1, 70710-1129-2, 70710-1129-4 +7 more
- Sizes
- 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. The 10 mg tablets come in 100-count Rx bottles distributed in the U.S. by Zydus Pharmaceuticals USA.
Why This Is Dangerous
An impurity, N-Nitroso Desmethyl Chlorpromazine, was detected at levels above the acceptable intake limit during CGMP testing. Long-term exposure carries potential health risks.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Patients currently taking this medication may need medical guidance to discuss alternatives. No injuries have been reported to date; exposure to the impurity remains a safety concern.
Practical Guidance
How to identify if yours is affected
- Check the bottle label for NDC 70710-1129-1.
- Look for Lot numbers Z403012 or Z406657.
- Verify expiration dates 30-Apr-2026 or 30-Nov-2026.
Where to find product info
FDA recall notice (D-0630-2025) and product labeling. See https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0630-2025
What timeline to expect
Refunds or replacements, if offered, typically take weeks after submission. Follow physician guidance.
If the manufacturer is unresponsive
- File a complaint with the FDA recall process
- Consult your pharmacist for alternatives
- Keep records of all communications and notices.
How to prevent similar issues
- Verify CGMP compliance before distributing drug products and check impurity testing results.
- Always check NDC and lot codes when sourcing medications.
- Discuss any medication substitutions with a healthcare professional before making changes.
Documentation advice
Keep the recall notice, bottle label, NDC, lot numbers, and expiration dates. Record all communications with the manufacturer and pharmacy.
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Product Details
NDC 70710-1129-1; 100-count bottles; Rx only; Manufactured by Zydus Lifesciences Ltd., Baddi, India; Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ; Sold nationwide in USA; Recall date 2025-09-03; FDA status Active; Lots Z403012 (Exp 30-04-2026) and Z406657 (Exp 30-11-2026)
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Lot numbers Z403012 and Z406657
- Exp 30-Apr-2026 and 30-Nov-2026
- Manufactured in India; distributed 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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