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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 #: 5PB0563, Exp 4/30/2027
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, above the acceptable daily intake (ADI).

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 Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059 foreign manufacturer
Brand nameCINACALCET
Generic nameCINACALCET
Active ingredient(s)CINACALCET HYDROCHLORIDE
Distributed by / forCipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059
NDC69097-412-02
Show the full FDA record
Full product labelCinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-412-02
Recalling firmCipla USA, Inc.
DistributionUSA Nationwide
QuantityN/A
Recall initiated2026-06-29
Report date2026-07-08
Recall completed—
Recall numberD-0676-2026
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.