Quick Facts at a Glance
- Recall Date
- August 27, 2025
- Hazard Level
- HIGH
- Brands
- Chlorpromazine Hydrochloride, American Health Packaging
- 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, American Health Packaging
- Product type
- Chlorpromazine Hydrochloride Tablets
- Model numbers
- Lot: 1021640, Lot: 1022639
- UPC codes
- 60687-419, 60687-430, 60687-441, 60687-452, 60687-463, 60687-419-11, 60687-419-01, 60687-430-11 +7 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 27, 2025
Reported by FDA DRUG
September 24, 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 at the manufacturing site, 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 Amerisource Health Services LLC or your healthcare provider for guidance. Notification method: Letter
About This Product
Chlorpromazine Hydrochloride is an antipsychotic medication used to treat various mental health conditions. Consumers buy it for its effectiveness in managing symptoms of schizophrenia and other disorders.
Why This Is Dangerous
The recall was issued due to a foreign substance found in the packaging material, specifically a micro-organism in the auxiliary polyester coil used for packaging. This poses a health risk, although no contamination was found on the tablets themselves.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face inconvenience as they must stop using the product and seek alternatives while awaiting guidance for a return.
Practical Guidance
How to identify if yours is affected
- Check the packaging for lot numbers: 1021640 or 1022639.
- Identify if you've purchased Chlorpromazine Hydrochloride Tablets, USP, 200 mg.
- Review any correspondence from your healthcare provider regarding this recall.
Where to find product info
Look for the lot numbers on the back of the carton or blister packs of the medication.
What timeline to expect
Expect a refund or guidance within 4-6 weeks from contacting Amerisource Health Services.
If the manufacturer is unresponsive
- Contact the FDA for reporting issues or lack of response from the manufacturer.
- Document all communication attempts for your records.
- Consider seeking legal advice if no resolution is reached.
How to prevent similar issues
- Verify packaging integrity before purchasing medications in the future.
- Check for any recalls regularly on the FDA website.
- Ensure medications are sourced from reputable pharmacies.
Documentation advice
Keep all receipts, correspondence, and photos of the product as documentation for your refund process.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Product: Chlorpromazine Hydrochloride Tablets, USP, 200 mg NDC: 60687-463-01 Distributed by: American Health Packaging, Columbus, Ohio Quantity Recalled: 873 cartons Model Numbers: Lot: 1021640, Lot: 1022639
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 873 cartons recalled nationwide
- Associated with Chlorpromazine Hydrochloride Tablets, USP, 200 mg
- Packaging found to contain foreign substance
- Contact Amerisource Health Services for guidance
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.