Zydus Lifesciences Ltd. recalled Chlorpromazine Hydrochloride Tablets on September 3, 2025. The recall affects products with NDC 16714-050-01 due to high levels of a chemical impurity. Consumers should stop using the tablets immediately and contact healthcare providers.
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: N/A
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The recalled product is Chlorpromazine Hydrochloride Tablets, USP, 100 mg, in 100-count bottles. The product is manufactured by Zydus Lifesciences Ltd. in Baddi, India, and distributed by Northstar Rx LLC in Memphis, TN. The affected lot numbers include Z305456, Z401156, and Z407306.
The recall stems from CGMP deviations due to the presence of N-Nitroso Desmethyl Chlorpromazine above acceptable limits. This impurity poses a significant risk to consumers, potentially leading to serious health issues.
No specific incidents or injuries have been reported at this time. The recall is classified as Class II, indicating a potential for serious adverse health consequences.
Stop using the recalled tablets immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for further guidance.
For more information, consumers can visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0637-2025.
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