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Cinacalcet Hydrochloride Tablets recall

Cipla USA, Inc. recalled Cinacalcet Hydrochloride Tablets on April 22, 2026 because of cGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit. It was sold nationwide.

Why it was recalled

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

What's recalled

Cinacalcet Hydrochloride Tablets, 30 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: 69097-410-02

Quantity: 113,336 bottles

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Cipla USA, Inc., Warren, NJ
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Nationwide in the USA
Status
Ongoing
Recall number
D-0449-2026
Source
U.S. Food and Drug Administration

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