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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Cinacalcet Hydrochloride Tablets are used to treat conditions related to elevated parathyroid hormone levels, often prescribed for patients with chronic kidney disease or hyperparathyroidism. Patients buy these tablets for their potential to manage calcium and phosphorus levels in the body effectively.
The recall is due to the presence of N-nitroso-cinacalcet, a nitrosamine impurity, which exceeds acceptable levels. Nitrosamines can form during the manufacturing process and have been linked to cancer risk.
This recall is not part of a broader industry pattern.
Consumers must stop using the product immediately due to the potential health risks associated with nitrosamine exposure. This may lead to inconvenience as patients seek alternatives or consult their healthcare providers.
Lot numbers and expiration dates are typically printed on the label or the bottom of the bottle.
Expect a refund or replacement to be processed within 4-6 weeks after returning the product.
Document your purchase by keeping receipts and any correspondence with the manufacturer regarding the recall.
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.
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