Cipla USA, Inc. recalled 63,504 bottles of Cinacalcet Hydrochloride Tablets on November 14, 2025. The recall results from a nitrosamine impurity, N-nitroso-cinacalcet, exceeding acceptable daily intake limits. Consumers should stop using the tablets 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, 30 mg, sold in bottles of 30 tablets. The affected lot numbers are 4PB0109 (expiry 1/31/2026) and 5PB0172 (expiry 1/31/2027). These tablets were distributed nationwide in the U.S.
The recall stems from the presence of a nitrosamine impurity, N-nitroso-cinacalcet, at levels above the acceptable daily intake limits. Nitrosamines are classified as potential carcinogens, posing a serious health risk to consumers.
Consumers and healthcare providers should stop using Cinacalcet Hydrochloride Tablets immediately. For further guidance, contact Cipla USA, Inc. or consult with a healthcare provider. A notification letter regarding the recall has been issued.
For questions about the recall, call Cipla USA, Inc. at 1-800-XXX-XXXX or visit their website at www.cipla.com.
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