Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cinacalcet Hydrochloride Tablets Recalled by Cipla USA, Inc. Due to CGMP Deviations: the presence of a nitrosamine impurity,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cipla USA, Inc. directly.
Affected 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
Quantity: 63,504 bottles
Why Was This Recalled?
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cipla USA, Inc.
Cipla USA, Inc. has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report