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, PREGNANT
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: 1022159, Lot: 1023299, Lot: 1024057
- UPC codes
- 60687-419, 60687-430, 60687-441, 60687-452, 60687-463, 60687-419-11, 60687-419-01, 60687-430-11 +7 more
- Sizes
- 50 mg
- 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 psychotic disorders. It is typically prescribed by healthcare providers. The packaging involves blister packs and carton packaging.
Why This Is Dangerous
A foreign substance associated with an auxiliary polyester coil packaging component was detected at the manufacturing site. No micro-organism was found on tablets.
Industry Context
This recall appears not to be part of a broader industry pattern.
Real-World Impact
High severity due to potential packaging contamination risk. Immediate cessation of use advised.
Practical Guidance
How to identify if yours is affected
- Check carton label for NDC 60687-441-01 and individual-dose NDC 60687-441-11
- Verify packaging material for polyester coil components
Where to find product info
FDA enforcement report D-0648-2025 and recall notices
What timeline to expect
Refunds/replacements will be processed after recall communications, typically weeks
If the manufacturer is unresponsive
- File a complaint with FDA
- Contact pharmacist or healthcare provider for guidance
How to prevent similar issues
- Verify packaging integrity on all medications
- Purchase from reputable pharmacies
- Keep lot information for future recalls
Documentation advice
Keep all recall letters, packaging, and prescription records
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Product Details
Product: Chlorpromazine Hydrochloride Tablets, USP 50 mg. Pack: 100 tablets per blisterpack, 10x10 blisters. Carton: 50 tablets in carton, NDC 60687-441-01, individual-dose NDC 60687-441-11. Distributor: Amerisource Health Services LLC doing business as American Health Packaging, Columbus, Ohio 43217. Quantity: 1,062 cartons. Distribution: Nationwide in the USA. Status: Active recall as of 2025-09-24.
Reported Incidents
No tablets were contaminated with micro-organisms. The notice indicates a foreign substance risk tied to packaging materials.
Key Facts
- Distributor: American Health Packaging
- Quantity recalled: 1,062 cartons
- Status: Active recall as of 2025-09-24
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Safety Guide
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