Class IIOngoing

Cinacalcet Tablets recall

FDA recall D-0079-2025 · initiated Nov 7, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Details

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 65862-833-30 90 mg - 500 Tablets - NDC 65862-833-05
Recalling company: Aurobindo Pharma Limited
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: USA Nationwide
Initiated: Nov 7, 2024
FDA report date: Dec 11, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0079-2025 ↗

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