HIGH

AvKare Recalls Chlorpromazine Tablets Due to Foreign Substance

AvKare recalled 2,003 cartons of Chlorpromazine Hydrochloride Tablets on August 25, 2025. The recall stems from the presence of a foreign substance in the medication. Consumers should stop using the product immediately and seek guidance from healthcare providers.

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

Product Details

The recalled product is Chlorpromazine Hydrochloride Tablets, USP, 100 mg, packaged in 50-tablet cartons. Lot numbers include 47089 and 47604, with expiration dates of December 31, 2025, and March 31, 2026. The medication was distributed nationwide in the USA.

The Hazard

The recall is classified as Class II due to the potential health risks associated with the presence of a foreign substance in the tablets. This could pose a serious health risk to consumers.

Reported Incidents

There are no reported incidents or injuries associated with this recall at this time. Consumers are advised to discontinue use as a precaution.

What to Do

Consumers should stop using the recalled Chlorpromazine Hydrochloride Tablets immediately. Contact AvKARE or consult a healthcare provider for further guidance on the recall.

Contact Information

For more information, consumers can email AvKARE or visit their website. The FDA recall notice can also be found at the provided link.

Key Facts

  • Recalled product: Chlorpromazine Hydrochloride Tablets
  • Recall date: August 25, 2025
  • Quantity: 2,003 cartons
  • Hazard: Presence of a foreign substance
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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 # 47089
Exp 12/31/25
47604
Exp 03/31/26
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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