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High risk Drugs & MedicationsClass II

Cipla Cinacalcet Hydrochloride Recall

Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured

Updated March 16, 2026

Cipla USA is recalling Cinacalcet Hydrochloride 30 mg tablets because they contain higher-than-safe levels of an impurity called N-Nitroso Cinacalcet. Long-term exposure to this impurity above the acceptable daily intake limit may increase cancer risk.

Is the Cipla USA, Inc. recalled? Yes. This product was recalled by FDA on March 16, 2026. Details below.

What is recalled

Cinacalcet Hydrochloride Tablets, 30 mg, 30 tablets per bottle, NDC 69097-410-02, manufactured by Cipla Ltd., MIDC, Patalganga, India, and distributed by Cipla USA, Inc., Warren, NJ.

Am I affected

You're affected if you have a prescription bottle of Cinacalcet Hydrochloride 30 mg tablets with NDC number 69097-410-02 on the label.

What to do right now

Stop taking this medication and contact your pharmacy or doctor right away. Do not return unused tablets to a pharmacy; instead, ask your doctor about a safe disposal method. Your doctor can switch you to an unaffected alternative or provide guidance on next steps.

The hazard

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

Brands affected

Cipla USA, Inc.
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0449-2026
Classification
Class II
Recalled
March 16, 2026
Read the official notice

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