Cinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding FDA Safety Limit
Aurobindo Pharma USA recalls Cinacalcet 90 mg tablets nationwide due to N-nitroso impurity exceeding FDA's interim safety limit. The impurity is a known carcinogenic compound.
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 involving a known carcinogenic impurity in a systemic prescription medication. Although no illnesses or injuries have been reported, the potential for harm from prolonged exposure to a carcinogenic substance qualifies this as a high-risk product recall.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Cinacalcet 90 mg tablets nationwide. The affected lots are CFSC23001A, CFSC23001B (expiring 03/31/2025) and P2300195 (expiring 12/31/2024), distributed in 30-count and 500-count bottles.
The recall is due to N-nitroso Cinacalcet impurity present above FDA's recommended interim limit. This impurity resulted from manufacturing deviations classified as current good manufacturing practice (cGMP) violations. N-nitroso compounds are known carcinogens.
Cinacalcet is a prescription medication used to treat secondary hyperparathyroidism. Patients taking the affected lots may have been exposed to elevated levels of this carcinogenic impurity.
Patients should contact their healthcare provider or pharmacist before making any changes to their medication. Do not discard medication without medical guidance; speak with a pharmacist about proper disposal. For additional information, contact Aurobindo Pharma USA Inc. or visit the FDA's drug recall database.
The recalled product
- Product
- CINACALCET (CINACALCET)
- Brand
- CINACALCET
- Manufacturer
- Aurobindo Pharma USA Inc
- Category
- Drug — Prescription / Oral
- Hazard
- n-nitroso-impurity
- carcinogenic
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 #: a) CFSC23001A
- CFSC23001B
- Exp 03/31/2025
- b) P2300195
- Exp 12/31/2024
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CINACALCET
- HighPrescription Cinacalcet Tablets Recalled for N-Nitroso Impurity
FDA (Drugs) · 2024-12-11
- HighFDA Recalls Cinacalcet 30mg Tablets for N-nitroso Impurity
FDA (Drugs) · 2024-12-11
- HighPrescription Drug Recall: Cinacalcet Tablets for N-nitroso Impurity
FDA (Drugs) · 2024-11-06
- HighAccord Healthcare Recalls Cinacalcet Tablets Due to Nitrosamine Contamination
FDA (Drugs) · 2024-11-06
- HighCinacalcet tablets recalled for nitroso impurity above FDA limits
FDA (Drugs) · 2024-11-06
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- SevereErythromycin Tablets Recalled for Impurity Above Acceptable Limits
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- ModeratePrimidone Tablets Recalled Due to API Cross-Contamination
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27