Cipla USA, Inc. recalled 15,744 bottles of Cinacalcet Hydrochloride Tablets on November 14, 2025. The recall follows the discovery of a nitrosamine impurity exceeding acceptable daily intake limits. Consumers should stop using the product immediately and consult healthcare providers.
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, 60 mg, sold in 30-tablet bottles. The affected lot is Lot 5PB0164, which has an expiration date of January 31, 2027. The product was distributed nationwide in the United States.
This recall addresses CGMP deviations due to the presence of N-nitroso-cinacalcet, a nitrosamine impurity. This substance poses potential health risks when consumed above acceptable daily intake limits.
No specific incidents of illness or injury have been reported at this time. However, the potential risk is classified as high due to the nature of the impurity.
Consumers and healthcare providers should stop using the tablets immediately. Contact Cipla USA, Inc. or consult your healthcare provider for further guidance. The company will notify affected customers via letter.
For more information, contact Cipla USA, Inc. at their headquarters in Warren, NJ. Visit the FDA recall report at the provided link for further details.
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