Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cinacalcet Tablets Recalled by Aurobindo Pharma USA Inc Due to cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Aurobindo Pharma USA Inc directly.
Affected Products
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
Why Was This Recalled?
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Aurobindo Pharma USA Inc
Aurobindo Pharma USA Inc has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report