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
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, 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: 1021652, Lot: 1022539, Lot: 1023666
- UPC codes
- 60687-419, 60687-430, 60687-441, 60687-452, 60687-463, 60687-419-11, 60687-419-01, 60687-430-11 +7 more
- Sizes
- 100 mg tablets
- Sold at
- Unknown
- 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 certain psychiatric conditions. It is distributed to healthcare facilities and pharmacies.
Why This Is Dangerous
A foreign substance from packaging coil carried a microorganism. Tablets themselves were free of microorganisms.
Industry Context
This recall is not part of a broader pattern at this time.
Real-World Impact
No injuries reported. Consumers should stop using the affected lots and await guidance.
Practical Guidance
How to identify if yours is affected
- Check carton NDC: 60687-452-01
- Check blister NDC: 60687-452-11
- Confirm lot numbers 1021652, 1022539, 1023666 and exp dates
- Look for packaging material: auxiliary polyester coil presence
Where to find product info
FDA recall page D-0649-2025 and enforcement reports
What timeline to expect
Refund or replacement notification via letter; timeline not specified
If the manufacturer is unresponsive
- File a report with FDA recall program
- Contact healthcare provider for interim guidance
- Keep records of correspondence
How to prevent similar issues
- Verify packaging certification and supplier quality controls
- Report packaging issues to the pharmacy or manufacturer
- Stay updated with FDA recall notices
Documentation advice
Save recall letter, take photos of packaging and lot codes
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Product Details
Product: Chlorpromazine Hydrochloride Tablets, USP 100 mg. Packaging: 100 tablets per carton, 10x10 blister packs. Distribution: Nationwide in the USA. Distributor: American Health Packaging, Columbus, OH. Carton NDC: 60687-452-01. Individual NDC: 60687-452-11. Quantity recalled: 1,757 cartons. Lot numbers and expirations in use: 1021652 (Exp 10/31/2026), 1022539 (Exp 01/31/2027), 1023666 (Exp 03/31/2027).
Reported Incidents
No injuries reported. The hazard is contamination risk; no patient injuries documented in the recall notice.
Key Facts
- Queen: 1,757 cartons recalled
- NDC: 60687-452-01 (carton); 60687-452-11 (individual blister)
- Distributor: American Health Packaging
- Country of origin: Unknown
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Safety Guide
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