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 25 mg
- Model numbers
- Z305060, Z305061, Z306323, Z401153, Z403015, Z403016, Z405591
- 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. It is prescribed by healthcare providers and distributed nationally in the United States.
Why This Is Dangerous
The recall is due to CGMP deviations and the presence of an impurity above acceptable intake limits, which could pose health risks with exposure.
Industry Context
This recall is not described as part of a broader industry pattern in the provided notice.
Real-World Impact
For patients currently using this medication, stopping therapy should be done under clinician guidance to avoid withdrawal or symptom recurrence.
Practical Guidance
How to identify if yours is affected
- Check the bottle label for NDC 70710-1130-1
- Confirm 100-count bottle size and Rx-only status
- Verify the distribution country as the USA
- Refer to the FDA recall page for the official recall number D-0632-2025
Where to find product info
FDA recall enforcement page for D-0632-2025 and the manufacturer communications
What timeline to expect
Refunds or replacements typically 4-6 weeks after submission
If the manufacturer is unresponsive
- Escalate with your pharmacist or clinician
- Submit complaints to FDA recall page if the company is unresponsive
- Keep copies of all correspondence and receipts
How to prevent similar issues
- Verify NDCs before dispensing any prescription drug
- Ask for manufacturer recall notices when starting therapy
- Consult your clinician before stopping medications without guidance
Documentation advice
Keep bottle, packaging, receipts, and any recall notices; document dates, conversations, and actions taken
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Product Details
NDC: 70710-1130-1; 25 mg tablets; 100-count bottles; Rx only; Manufactured by Zydus Lifesciences Ltd., Baddi, India; Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; Nationwide distribution in the USA; Recall date: 2025-09-03; Status: ACTIVE; Reason: CGMP Deviations: N-Nitroso Desmethyl Chlorpromazine above acceptable intake; Model numbers not specified.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Manufactured in India
- Distributed nationwide in the USA
- CGMP deviations cited
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Safety Guide
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