Prescription Drug Cinacalcet Tablets Recalled Due to Nitrosamine Impurity
Cipla USA is recalling Cinacalcet Hydrochloride Tablets because they contain higher-than-allowed levels of a nitrosamine impurity. The recall affects about 63,504 bottles distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—a nitrosamine impurity above acceptable daily intake limits—is theoretical rather than a documented safety event. Per the rubric, when no illnesses/injuries are reported and the hazard is theoretical, the maximum score is 3.
Plain-English summary
Cipla USA, Inc. is recalling Cinacalcet Hydrochloride Tablets, 30 mg. The recall affects 63,504 bottles distributed nationwide, including Lot 4PB0109 (expiring January 31, 2026) and Lot 5PB0172 (expiring January 31, 2027).
The recall results from a current good manufacturing practice (CGMP) deviation. The affected products contain the nitrosamine impurity N-nitroso-cinacalcet at levels above the FDA's acceptable daily intake limits. Nitrosamines are potential carcinogenic contaminants.
Patients taking Cinacalcet from the affected lots should contact their healthcare provider or pharmacist. Do not discontinue medication without medical guidance. Healthcare providers and pharmacies can verify lot numbers on bottles to determine if supplies are affected.
The recalled product
- Product
- CINACALCET (CINACALCET)
- Brand
- CINACALCET
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug
- Hazard
- nitrosamine-impurity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot
- expiry: Lot 4PB0109
- exp 1/31/2026
- Lot 5PB0172
- exp 1/31/2027
Distribution
Distributed nationwide across the United States.
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- HighCinacalcet tablets recalled due to N-nitroso impurity above acceptable limits
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- HighDrug Recall: Cinacalcet tablets contain excess nitrosamine impurity
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