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.
Presence of a foreign substance.
Consumers and healthcare providers should stop using this product immediately. Contact AvKARE or your healthcare provider for guidance. Notification method: E-Mail
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 presence of a foreign substance poses significant health risks. This issue falls under Class II recall, indicating a potential for serious health implications.
No specific incidents or injuries have been reported at this time. The recall was initiated due to the potential contamination risk.
Stop using the recalled tablets immediately. Contact AvKARE or your healthcare provider for further instructions.
For more information, email AvKARE or visit their website. Consumers can also find details at the FDA recall page.
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Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.