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.
No specific incidents of injury or illness have been reported related to this recall. However, the risk associated with nitrosamines is significant, necessitating immediate consumer action.
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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