FDA-Drug2025-12-17Class IICHEMICAL
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
Hazard
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the US
Affected count
63,504 bottles
Manufactured in
10 Independence Blvd, N/A, Warren, NJ, United States
Products
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0224-2026More Cipla recalls
- FDA-Drug2026-07-08Cipla Cinacalcet Hydrochloride 60 mg tablets recalled for N-nitroso impurity above safe limits
- FDA-Drug2026-07-08Cipla Cinacalcet Hydrochloride 90 mg tablets recalled for N-nitroso impurity above acceptable limits
- FDA-Drug2026-07-08Cipla Cinacalcet Hydrochloride 30 mg tablets recalled for N-nitroso impurity
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