Amneal Pharmaceuticals products containing chlorpromazine hydrochloride are recalled nationwide after the FDA-linked notice identifies a foreign substance in packaging material. No tablets were contaminated. The recall was issued August 18, 2025 and updated September 10, 2025. Consumers and healthcare providers should stop using the affected lots immediately and contact Amneal for guidance.
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 is an antipsychotic medication used to treat certain psychiatric conditions. It is only available by prescription.
A foreign substance in packaging, specifically a polyester coil, was detected with a microorganism. No contamination found in the tablets themselves.
This recall is not described as part of a broader industry pattern.
Consumers must stop using affected bottles. Healthcare providers should review patient safety and determine next steps.
Recall notice letters and FDA recall page D-0619-2025
Refunds or replacements will be issued per recall letters, typically within weeks to a couple of months
Keep copy of recall letters, receipts, and correspondence with manufacturer or pharmacy
Product: Chlorpromazine Hydrochloride Tablets, USP 200 mg, 100-count bottles. Manufacturer: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, India. Distributor: Amneal Pharmaceuticals LLC, Bridgewater, NJ. Distribution: Nationwide in the USA. NDC: 69238-1062-1. Lot numbers: AM240336, AM240337. Expiration: 02/28/2027. Quantity: 3,363 bottles.
No injuries or incidents have been reported.
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