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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC…
- Manufacturer
- Aurobindo Pharma USA Inc
- Category
- Drug — Prescription / Oral
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.
Part of a larger recall action
This product is one of 3 recalled by Aurobindo Pharma USA Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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