Amneal Pharmaceuticals recalled 13,130 bottles of Chlorpromazine Hydrochloride Tablets on August 18, 2025, due to contamination concerns. The recall affects specific lots identified by their lot numbers AM240147, AM240148, AM240664, and AM240665. Consumers should stop using the tablets immediately and contact their healthcare provider for further guidance.
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.
Consumers and healthcare providers should stop using this product immediately. Contact Amneal Pharmaceuticals, LLC or your healthcare provider for guidance. Notification method: Letter
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The recalled product is Chlorpromazine Hydrochloride Tablets, USP, 50 mg, in 100-count bottles. The affected lots are AM240147, AM240148, AM240664, and AM240665, with expiration dates of January 31, 2027, and April 30, 2027. The product was distributed nationwide in the USA.
The recall was initiated due to the presence of a foreign substance, specifically a micro-organism found on auxiliary polyester coil used in packaging. No micro-organisms were detected on the tablets themselves. This contamination poses a high risk to consumers.
There have been no reported injuries or illnesses associated with this recall. However, the potential risk from contaminated packaging warrants immediate action.
Stop using the recalled tablets immediately. Consumers should contact Amneal Pharmaceuticals, LLC or their healthcare provider for guidance regarding the recall.
For more information, consumers can visit the FDA website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0617-2025. Amneal Pharmaceuticals can also be contacted directly for further assistance.
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