American Health Packaging recalled 2,708 cartons of Chlorpromazine Hydrochloride Tablets on August 27, 2025. The recall follows the detection of a micro-organism in product packaging, though no contamination was found on the tablets themselves.
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
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, packaged in 50 (5x10) and 100 (10x10) blisterpacks. Distributed by American Health Packaging, Columbus, Ohio.
A foreign substance was detected in the auxiliary polyester coil used for packaging. This poses a high risk of contamination, though no micro-organisms were found on the tablets.
As of now, no injuries or illnesses have been reported related to this contamination issue. The risk remains due to the potential for exposure from the packaging.
Stop using the affected product immediately. Contact Amerisource Health Services LLC or your healthcare provider for guidance and possible return.
For more details, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0647-2025.
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