Amneal Pharmaceuticals recalled 3,363 bottles of Chlorpromazine Hydrochloride Tablets on August 18, 2025. The recall stems from the presence of a microorganism in packaging material. No microorganisms were detected in the tablets themselves, but consumers should stop using the product immediately.
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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The recalled product is Chlorpromazine Hydrochloride Tablets, USP, 200 mg, in 100-count bottles. The lot numbers affected are AM240336 and AM240337, with an expiration date of February 28, 2027. The product was distributed nationwide.
The recall is due to the presence of a foreign substance detected in auxiliary polyester coil used in packaging. Although no microorganisms were found in the tablets, the risk of contamination remains.
No incidents or injuries have been reported related to the contaminated packaging. The recall was initiated proactively to ensure consumer safety.
Stop using the recalled product immediately. Contact Amneal Pharmaceuticals, LLC or consult your healthcare provider for further guidance.
For more information, visit the FDA website or contact Amneal Pharmaceuticals at their customer service number.
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