HIGH

Chlorpromazine Hydrochloride Tablets Recalled Over Contamination Risk

American Health Packaging recalled 1,062 cartons of Chlorpromazine Hydrochloride Tablets on August 27, 2025. The recall stems from the detection of a micro-organism in auxiliary packaging materials. No micro-organism was found on the tablets themselves, but consumers should stop using the product immediately.

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

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, 50 mg, distributed in 100 blister packs. It carries NDC# 60687-441-01. The affected lot numbers are 1022159, 1023299, and 1024057.

The Hazard

The recall involves the presence of a foreign substance detected in the product packaging. A specific lot of auxiliary polyester coil was found to have a micro-organism, posing potential health risks.

Reported Incidents

No injuries or illnesses have been reported related to this recall. The manufacturer detected no micro-organism on any of the tablets.

What to Do

Consumers should stop using the recalled tablets immediately. Contact Amerisource Health Services LLC or consult your healthcare provider for further guidance.

Contact Information

For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0648-2025.

Key Facts

  • Recall date: August 27, 2025
  • Quantity recalled: 1,062 cartons
  • NDC#: 60687-441-01
  • No micro-organism detected on tablets

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: 1022159
Lot: 1023299
Lot: 1024057
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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