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Cinacalcet Hydrochloride Tablets
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DRUG RECALLMODERATE

Cinacalcet Hydrochloride Tablets

Cipla is recalling Cinacalcet Hydrochloride Tablets due to the presence of N-Nitroso Cinacalcet above acceptable limits.

What to do

Consult your healthcare provider or pharmacist regarding this recall and to discuss alternative treatment options.

Posted
Updated
Recall No.
D-0451-2026
Agency
Firm
Cipla USA, Inc.
Recall ID
98670
Status
ONGOING

Why it was recalled

CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

How to identify it

Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per 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

Where it was sold

Distributed in US.

Other recent recalls from Cipla USA, Inc.

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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification