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, 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, American Health Packaging
- Product type
- Chlorpromazine Hydrochloride Tablets
- Model numbers
- Lot: a)1020919, 1021133, Exp 09/30/2026, 1021447, Exp 10/31/2026, 1021741, 1022202, Exp 11/30/2026 +6 more
- 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
- 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 in blisterpackaged tablets.
Why This Is Dangerous
A foreign substance in packaging material was detected, with a microorganism present on the packaging coil. No tablets were found contaminated.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may need to stop taking the affected lot and work with healthcare providers to obtain a safe replacement, potential disruption to treatment timelines.
Practical Guidance
How to identify if yours is affected
- Check NDC 60687-430-65 (50 blisterpack) or 60687-430-01 (100 blisterpack)
- Check individual NDC 60687-430-11
- Inspect for Lot numbers starting with 1020xxx and Exp dates 2026
- Verify packaging coil material if visible on packaging
Where to find product info
Recall notices and FDA enforcement page D-0647-2025
What timeline to expect
Refunds/replacements via a letter notification; process timelines vary by distributor
If the manufacturer is unresponsive
- Escalate to consumer protection agencies
- File a formal complaint with the FDA
- Maintain records of all correspondence
How to prevent similar issues
- Check future drug packaging for foreign-material warnings
- Verify supplier quality controls
- Confirm lot and expiry dates before use
- Keep documentation for refunds
Documentation advice
Keep all recall notices, packaging, lot numbers, and correspondence for records
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Product Details
Brand: CHLORPROMAZINE HYDROCHLORIDE. Distributor: American Health Packaging, Columbus, Ohio 43217. Packaging options: a) 50 blisterpacks (5x10) NDC 60687-430-65; Individual Dose NDC 60687-430-11; b) 100 blisterpacks (10x10) NDC 60687-430-01; Individual Dose NDC 60687-430-11. Quantity recalled: 2,708 cartons. Class II recall. Distribution: Nationwide in the USA. Recall date: 2025-08-27.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Packaging material: auxiliary polyester coil with detected microorganism
- Hazard level: HIGH
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Safety Guide
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