Amneal Pharmaceuticals recalled 7,228 bottles of Chlorpromazine Hydrochloride Tablets on August 18, 2025. The recall occurred due to the presence of a micro-organism in the packaging material. No micro-organisms were found on the tablets themselves.
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, 25 mg, sold in 100-count bottles. The affected lot numbers include AM240617 and AM240618, with an expiration date of April 30, 2027. The product was distributed nationwide in the USA.
The recall stems from the detection of a micro-organism in a specific lot of auxiliary polyester coil used in product packaging. This poses a potential contamination risk to consumers, although no micro-organisms were found on any of the tablets.
There are no reported incidents of illness or injury associated with the recalled tablets. The recall is classified as Class II due to the potential risk.
Consumers should stop using the recalled tablets immediately. Contact your healthcare provider or Amneal Pharmaceuticals, LLC for further guidance and information on how to dispose of the product.
For questions, call Amneal Pharmaceuticals at 1-XXX-XXXX. More information is available on the FDA's website.
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