Cipla USA recalled 12,576 bottles of Cinacalcet Hydrochloride Tablets on November 14, 2025, due to a nitrosamine impurity. The impurity, N-nitroso-cinacalcet, exceeds acceptable daily intake limits. Consumers must stop using this product immediately and contact healthcare providers for guidance.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Consumers and healthcare providers should stop using this product immediately. Contact Cipla USA, Inc. or your healthcare provider for guidance. Notification method: Letter
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The recall involves Cinacalcet Hydrochloride Tablets, 90 mg, sold in bottles of 30. The affected lot number is Lot 5PB0183, with an expiration date of January 31, 2027.
This recall stems from CGMP deviations, specifically the presence of a nitrosamine impurity above acceptable daily intake limits. N-nitroso-cinacalcet has raised concerns due to its potential health risks.
No injuries or incidents have been reported related to this recall. The impurity poses a high risk, prompting immediate action.
Consumers should stop using the affected tablets immediately. Contact Cipla USA, Inc. or your healthcare provider for further guidance.
To report issues or seek more information, contact Cipla USA, Inc. at their website or via the FDA's recall page.
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