HIGH

American Health Packaging Recalls Chlorpromazine Tablets Over Contamination Risk

American Health Packaging recalled 1,757 cartons of Chlorpromazine Hydrochloride Tablets on August 27, 2025. The recall stems from the detection of a microorganism in packaging materials, though no contamination was found on the tablets themselves. Consumers should stop using the product immediately and contact healthcare providers for guidance.

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

Product Details

The recalled product is Chlorpromazine Hydrochloride Tablets, USP, 100 mg, packaged in 100 (10x10) blister packs per carton. The affected lot numbers include 1021652, 1022539, and 1023666, with expiration dates ranging from January 31, 2027, to March 31, 2027.

The Hazard

The recall involves the presence of a microorganism detected in auxiliary polyester coil packaging. This poses a risk to consumers, although the tablets themselves tested negative for contamination.

Reported Incidents

No injuries or incidents have been reported related to this contamination. The recall is classified as Class II due to the potential risk associated with the packaging.

What to Do

Consumers should stop using the recalled Chlorpromazine Hydrochloride Tablets immediately. They can contact Amerisource Health Services LLC or their healthcare provider for further guidance.

Contact Information

For more information, consumers can visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0649-2025.

Key Facts

  • Recall date: August 27, 2025
  • 1,757 cartons recalled nationwide
  • No contamination found on tablets
  • Contact healthcare provider for guidance
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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeChlorpromazine Hydrochloride Tablets
Sold At
Multiple Retailers

Product Details

Model Numbers
Lot: 1021652
Exp 10/31/2026
1022539
Exp 01/31/2027
1023666
+1 more
UPC Codes
60687-419
60687-430
60687-441
+12 more
Affected States
ALL
Report Date
September 24, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE
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