AvKare recalls 2,003 cartons of CHLORPROMAZINE HYDROCHLORIDE 100 mg tablets sold nationwide in the United States after a foreign substance was found. The FDA-listed Class II recall is in effect as of 2025-08-25. Stop using the product and contact AvKare or your healthcare provider for guidance.
Presence of a foreign substance.
Consumers and healthcare providers should stop using this product immediately. Contact AvKARE or your healthcare provider for guidance. Notification method: E-Mail
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Chlorpromazine hydrochloride is an antipsychotic medication used to treat schizophrenia and other psychiatric conditions. It is prescription-only and supplied in unit-dose cartons.
A foreign substance detected in the tablets poses a potential risk if ingested and requires immediate cessation of use.
This recall is not part of a broader industry pattern.
Immediate cessation is required to minimize any potential exposure risk. Patients should contact their healthcare provider for guidance.
FDA recall page and AvKare communications; NDC and lot numbers are on the carton label.
Refunds or replacements will be coordinated by AvKare; timelines to be provided by the company.
Keep recall notices, packaging, receipts, and correspondence for records
Product: CHLORPROMAZINE HYDROCHLORIDE tablets, 100 mg, 50 tablets per carton. Form: Unit dose carton (5x10). Rx only. Manufactured for: AvKare, Pulaski, TN 38478. NDC: 50268-165-15. Quantity: 2003 cartons. Distribution: USA Nationwide. Existing brands: CHLORPROMAZINE HYDROCHLORIDE, AvPAK. Lot numbers: 47089; 47604. Expiration: 12/31/2025 and 03/31/2026.
No injuries or incidents have been reported in the provided data.
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