American Health Packaging recalled 873 cartons of Chlorpromazine Hydrochloride Tablets on August 27, 2025. The recall stems from the presence of a micro-organism in 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 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
The recalled product includes Chlorpromazine Hydrochloride Tablets, USP, 200 mg, distributed in 100-count blister packs. The affected lot numbers are 1021640 (expiring on 10/31/2026) and 1022639 (expiring on 01/31/2027).
The recall involves a specific lot of auxiliary polyester coil used in packaging, which tested positive for a micro-organism. This poses a potential health risk, classified as Class II by the FDA.
No micro-organisms have been detected on the tablets themselves. There are no reported incidents of illness or injury related to this recall.
Consumers and healthcare providers should stop using the recalled product immediately. Contact Amerisource Health Services LLC or consult your healthcare provider for further guidance.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0650-2025 or contact Amerisource Health Services LLC.
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