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Class II · ModerateActive recall

Cinacalcet

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

Does this affect you?
Check your lot numberLot 5PB0164, exp 1/31/2027
Where it was soldNationwide in the US
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: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

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 byCipla USA Inc.
Brand nameCINACALCET
Generic nameCINACALCET
Active ingredient(s)CINACALCET HYDROCHLORIDE
Distributed by / forCipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059
NDC69097-411-02
Show the full FDA record
Full product labelCinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
Recalling firmCipla USA, Inc.
DistributionNationwide in the US
Quantity15,744 bottles
Recall initiated2025-11-14
Report date2025-12-17
Recall completed—
Recall numberD-0225-2026
ClassificationClass II
FDA statusOngoing
Origin on fileWarren 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.