HIGH

Amneal Pharmaceuticals Recalls Chlorpromazine Tablets Over Contamination Risk

Amneal Pharmaceuticals recalled 14,923 bottles of Chlorpromazine Hydrochloride Tablets on August 18, 2025. A specific lot of polyester coil used in product packaging tested positive for a micro-organism. No contamination was found in the tablets themselves.

Quick Facts at a Glance

Recall Date
August 18, 2025
Hazard Level
HIGH
Brands
Chlorpromazine Hydrochloride, Amneal Pharmaceuticals
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 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 Amneal Pharmaceuticals, LLC or your healthcare provider for guidance. Notification method: Letter

Product Details

The recalled product is Chlorpromazine Hydrochloride Tablets, 100 mg in 100-count bottles. The affected lot numbers include AM240334, AM240335, and AM241031. The tablets were distributed nationwide in the USA.

The Hazard

The recall stems from the presence of a foreign substance in the packaging. A specific lot of auxiliary polyester coil tested positive for a micro-organism, posing potential health risks.

Reported Incidents

No incidents or injuries related to the contamination have been reported. The tablets themselves remain uncontaminated.

What to Do

Stop using the recalled product immediately. Contact Amneal Pharmaceuticals or your healthcare provider for further guidance.

Contact Information

For more information, call Amneal Pharmaceuticals at 1-800-XXX-XXXX or visit their website at www.amneal.com.

Key Facts

  • Recall date: August 18, 2025
  • Lot numbers affected: AM240334, AM240335, AM241031
  • No contamination detected in tablets
  • Distributed nationwide in the USA
  • Contact manufacturer 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: AM240334
AM240335
AM241031
UPC Codes
69238-1054
69238-1056
69238-1058
+7 more
Affected States
ALL
Report Date
September 10, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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