AvKare recalled 1,512 cartons of CHLORPROMAZINE HYDROCHLORIDE 50 mg tablets distributed nationwide in the U.S. for the presence of a foreign substance. The recall is active as of Sept. 17, 2025. Consumers and healthcare providers should stop using this product immediately and contact AvKARE or a 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 for various psychiatric conditions. The 50 mg tablet is supplied in unit-dose cartons for clinical use.
Contamination with foreign substances can cause adverse reactions or require medical evaluation. Consumers should avoid use until guidance is provided by AvKare.
This recall is not part of a broader industry pattern in this dataset.
Immediate halt to use is required to prevent potential adverse events. Patients may require clinical guidance and possible product replacement.
NDC on front panel; lot number and expiration date on carton and seal
Replacement or refund process not specified; follow manufacturer guidance; anticipated processing timelines typical for drug recalls (weeks to months)
Keep recall notice, purchase records, lot numbers, expiration dates, and all correspondence
Product: CHLORPROMAZINE HYDROCHLORIDE tablets, 50 mg, 50 tablets per carton (5x10 unit dose). NDC 50268-164-15. Sold nationwide in the USA. Manufacturer: AvKare, Pulaski, TN 38478. Quantity: 1,512 cartons. Lot numbers/Exp: Lot # 46824; Exp 9/30/25; Lot 47171; Exp 12/31/25. Status: Active recall as of 2025-08-25; Report date 2025-09-17.
No injuries or incidents have been reported in the provided recall notice.
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