Quick Facts at a Glance
- Recall Date
- August 18, 2025
- Hazard Level
- HIGH
- Brands
- Chlorpromazine Hydrochloride, Amneal 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, Amneal Pharmaceuticals
- Product type
- Chlorpromazine Hydrochloride Tablets
- Model numbers
- AM240334, AM240335, AM241031
- UPC codes
- 69238-1054, 69238-1056, 69238-1058, 69238-1060, 69238-1062, 69238-1054-1, 69238-1056-1, 69238-1058-1 +2 more
- Sizes
- 100-count bottles
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 18, 2025
Reported by FDA DRUG
September 10, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Amneal Pharmaceuticals, LLC or your healthcare provider for guidance. Notification method: Letter
About This Product
Chlorpromazine hydrochloride is an antipsychotic medication used to treat certain psychiatric conditions. It is distributed in the United States through a network of healthcare providers.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Consumers may need to switch medications under supervision. There is no reported contamination of tablets, but packaging contamination could pose health risks.
Practical Guidance
How to identify if yours is affected
- Check if your bottle bears NDC 69238-1060-1.
- Look for lot numbers AM240334, AM240335, AM241031 on the bottle/box.
- Confirm packaging uses auxiliary polyester coil as described in the recall.
Where to find product info
NDC and lot codes on label; recall notice provides official details.
What timeline to expect
Recall processing timelines are not specified in the notice.
If the manufacturer is unresponsive
- Document all communications with the company and healthcare provider.
- Escalate to FDA recall contacts if no response is received within a reasonable timeframe.
- Consider filing a report with the FDA if you suspect unsafe conditions.
How to prevent similar issues
- If purchasing prescription meds, verify packaging quality and lot numbers.
- Consult your healthcare provider for approved alternatives if you must switch meds.
- Maintain a record of recall notices and medication changes.
Documentation advice
Keep bottle, packaging, and recall notices. Save correspondence with the company and healthcare providers.
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Product Details
NDC: 69238-1060-1. Sold nationwide in the USA. 14,923 bottles recalled. Lot numbers AM240334, AM240335, AM241031. 100 mg tablets in 100-count bottles. Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, India. Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. Classification: Class II. Product type: Oral solid dosage unit (Tablets).
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 14,923 bottles recalled nationwide
- Lot numbers AM240334, AM240335, AM241031
- Manufactured in India; distributed by US-based affiliate
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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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