Quick Facts at a Glance
- Recall Date
- August 18, 2025
- Hazard Level
- HIGH
- Brands
- Chlorpromazine Hydrochloride, Amneal Pharmaceuticals
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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
- Lot AM240336, Lot AM240337, Exp 02/28/2027
- 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
- Unknown
- 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 is an antipsychotic medication used to treat certain psychiatric conditions. It is only available by prescription.
Why This Is Dangerous
A foreign substance in packaging, specifically a polyester coil, was detected with a microorganism. No contamination found in the tablets themselves.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Consumers must stop using affected bottles. Healthcare providers should review patient safety and determine next steps.
Practical Guidance
How to identify if yours is affected
- Check bottle label for Chlorpromazine Hydrochloride 200 mg
- Inspect lot AM240336 or AM240337
- Check expiration date 02/28/2027
- Confirm bottle size: 100-count
Where to find product info
Recall notice letters and FDA recall page D-0619-2025
What timeline to expect
Refunds or replacements will be issued per recall letters, typically within weeks to a couple of months
If the manufacturer is unresponsive
- Document all attempts to contact the company
- File a report with CPSC or FDA if company is slow to respond
- Consult your pharmacist or physician for interim safety steps
How to prevent similar issues
- Verify packaging integrity before purchase
- Watch for packaging defects in future drug purchases
- Only obtain prescriptions through licensed pharmacies
- Keep a copy of the recall notice and patient safety information
Documentation advice
Keep copy of recall letters, receipts, and correspondence with manufacturer or pharmacy
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Product Details
Product: Chlorpromazine Hydrochloride Tablets, USP 200 mg, 100-count bottles. Manufacturer: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, India. Distributor: Amneal Pharmaceuticals LLC, Bridgewater, NJ. Distribution: Nationwide in the USA. NDC: 69238-1062-1. Lot numbers: AM240336, AM240337. Expiration: 02/28/2027. Quantity: 3,363 bottles.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Lot AM240336 and AM240337
- Package material contamination not found in tablets
- Active recall status as of 2025-09-10
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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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