HIGH

AvKare Recalls Chlorpromazine Hydrochloride Tablets Over Contamination Risk

AvKare recalled 1,512 cartons of Chlorpromazine Hydrochloride Tablets on August 25, 2025. The recall follows the discovery of a foreign substance in the medication. Consumers should stop using the product immediately and seek guidance from healthcare providers.

Quick Facts at a Glance

Recall Date
August 25, 2025
Hazard Level
HIGH
Brands
AvKare, CHLORPROMAZINE HYDROCHLORIDE
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Presence of a foreign substance.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact AvKARE or your healthcare provider for guidance. Notification method: E-Mail

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Product Details

The recalled product is Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 50 tablets per carton. Lot numbers include 46824 and 47171, with expiration dates of September 30, 2025, and December 31, 2025.

The Hazard

The presence of a foreign substance poses significant health risks. This issue falls under Class II recall, indicating a potential for serious health implications.

Reported Incidents

No specific incidents or injuries have been reported at this time. The recall was initiated due to the potential contamination risk.

What to Do

Stop using the recalled tablets immediately. Contact AvKARE or your healthcare provider for further instructions.

Contact Information

For more information, email AvKARE or visit their website. Consumers can also find details at the FDA recall page.

Key Facts

  • 1,512 cartons recalled
  • Manufactured for AvKARE in Pulaski, TN
  • Class II recall due to contamination risk
  • Stop using the product immediately
  • Contact healthcare providers 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 # 46824
Exp 9/30/25
47171
Exp 12/31/25
UPC Codes
50268-162
50268-163
50268-164
+12 more
Affected States
ALL
Report Date
September 17, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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