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Class II · ModerateActive recall

Cinacalcet Tablets

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: a) CFSC23001A, CFSC23001B, Exp 03/31/2025; b) P2300195, Exp 12/31/2024
Where it was soldUSA Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Distributed by / forAurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520
NDC65862-833-30
Show the full FDA record
Full product labelCinacalcet 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 firmAurobindo Pharma USA Inc
DistributionUSA Nationwide
Recall initiated2024-11-07
Report date2024-12-11
Recall completed—
Recall numberD-0079-2025
ClassificationClass II
FDA statusOngoing
Origin on fileEast Windsor NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.