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, 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, Amneal Pharmaceuticals
- Product type
- Chlorpromazine Hydrochloride 50 mg Tablets
- Model numbers
- AM240147, AM240148, AM240664, AM240665
- 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 bottle
- 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 disorders. It is prescribed by healthcare providers and distributed through pharmacies.
Why This Is Dangerous
A packaging coil used in the product’s packaging was found to contain a microorganism. The tablets themselves did not test positive for the microorganism.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Consumers must stop using affected bottles and await guidance for refunds or replacements. Patients may experience treatment interruptions if alternatives are not readily available.
Practical Guidance
How to identify if yours is affected
- Check the bottle label for NDC 69238-1058-1.
- Check the bottle lot numbers AM240147, AM240148, AM240664, AM240665.
- Compare against the recalled lots listed in the FDA notice.
Where to find product info
Recall details and identifiers can be found on the FDA enforcement page for D-0617-2025 and the Amneal recall notice.
What timeline to expect
Refund or replacement typically follows the recall process; consumer timelines vary, often 4-8 weeks for processing.
If the manufacturer is unresponsive
- Document all communications with the brand or pharmacy.
- File a complaint with CPSC or FDA if necessary.
- Seek assistance from your healthcare provider for alternative medications.
How to prevent similar issues
- Always check packaging integrity before use.
- Verify NDC and lot numbers with the recall list prior to dispensing or using meds.
- Buy medicines through licensed pharmacies and verify recall status before use.
- Keep recall documents and contact information handy for follow-up.
Documentation advice
Keep the recall notice, bottle labels, purchase receipts, and correspondence with the manufacturer for records.
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Product Details
NDC: 69238-1058-1. Product: Chlorpromazine Hydrochloride tablets, 50 mg, 100-count bottle. Sold nationwide in the USA. Manufacturer: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, India. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. Lot numbers: AM240147, AM240148, AM240664, AM240665. Quantity: 13,130 bottles. Class II recall. Date: 2025-08-18. Status: Active.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Manufacturer: Amneal Pharmaceuticals Pvt. Ltd. (India)
- Distributor: Amneal Pharmaceuticals LLC (USA)
- Packaged coil contamination detected; tablets unaffected by microorganism
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Safety Guide
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