American Health Packaging recalled 1,757 cartons of Chlorpromazine Hydrochloride Tablets on August 27, 2025. The recall stems from the detection of a microorganism in packaging materials, though no contamination was found on the tablets themselves. Consumers should stop using the product immediately and contact healthcare providers for guidance.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, 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 Amerisource Health Services LLC or your healthcare provider for guidance. Notification method: Letter
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The recalled product is Chlorpromazine Hydrochloride Tablets, USP, 100 mg, packaged in 100 (10x10) blister packs per carton. The affected lot numbers include 1021652, 1022539, and 1023666, with expiration dates ranging from January 31, 2027, to March 31, 2027.
The recall involves the presence of a microorganism detected in auxiliary polyester coil packaging. This poses a risk to consumers, although the tablets themselves tested negative for contamination.
No injuries or incidents have been reported related to this contamination. The recall is classified as Class II due to the potential risk associated with the packaging.
Consumers should stop using the recalled Chlorpromazine Hydrochloride Tablets immediately. They can contact Amerisource Health Services LLC or their healthcare provider for further guidance.
For more information, consumers can visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0649-2025.
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