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FDA · Drugs ·

Cinacalcet Hydrochloride Tablets recall

Cipla USA, Inc. recalled Cinacalcet Hydrochloride Tablets on July 8, 2026 because of cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). It was sold nationwide.

Why it was recalled

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

What's recalled

Cinacalcet Hydrochloride Tablets, 90 mg, 30-count 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

Quantity: N/A

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
USA Nationwide
Status
Ongoing
Recall number
D-0676-2026
Source
U.S. Food and Drug Administration

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