Amneal Pharmaceuticals recalled 13,130 bottles of CHLORPROMAZINE HYDROCHLORIDE 50 mg tablets distributed nationwide in the USA. A specific lot of auxiliary polyester coil used in packaging was found to contain a microorganism. No microorganism was detected on any tablets. Consumers and healthcare providers should stop using this product immediately and await further instructions from Amneal or a H
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging 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 Amneal Pharmaceuticals, LLC or your healthcare provider for guidance. Notification method: Letter
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Chlorpromazine hydrochloride is an antipsychotic medication used to treat certain psychiatric disorders. It is prescribed by healthcare providers and distributed through pharmacies.
A packaging coil used in the product’s packaging was found to contain a microorganism. The tablets themselves did not test positive for the microorganism.
This recall is not described as part of a broader industry pattern.
Consumers must stop using affected bottles and await guidance for refunds or replacements. Patients may experience treatment interruptions if alternatives are not readily available.
Recall details and identifiers can be found on the FDA enforcement page for D-0617-2025 and the Amneal recall notice.
Refund or replacement typically follows the recall process; consumer timelines vary, often 4-8 weeks for processing.
Keep the recall notice, bottle labels, purchase receipts, and correspondence with the manufacturer for records.
NDC: 69238-1058-1. Product: Chlorpromazine Hydrochloride tablets, 50 mg, 100-count bottle. Sold nationwide in the USA. Manufacturer: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, India. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. Lot numbers: AM240147, AM240148, AM240664, AM240665. Quantity: 13,130 bottles. Class II recall. Date: 2025-08-18. Status: Active.
No injuries or incidents have been reported.
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