FreshRecalls

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FDAClass II · Drug · Recalled July 8, 2026

Cinacalcet Hydrochloride Tablets recall — Cipla USA, Inc.

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
D-0675-2026
Brand
Cipla USA
Classification
Class II
Units affected
N/A
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

Cinacalcet Hydrochloride Tablets, 60 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 69097-411-02

Affected products

Companies & origin

Recalling firm location
Warren, NJ, United States
Firm address
10 Independence Blvd, N/A, 07059-2730

Identifying details (verbatim from the notice)

Product codes / lots
Lot #: 5PB0165, 5PB0166, Exp 1/31/2027; 5PB0552, Exp 4/30/2027; 5PB0642, 5PB0643, 5PB0644, Exp 6/30/2027
Distribution
USA Nationwide
Firm notified the public via
Letter
FDA event ID
99350
Recall initiated
June 29, 2026
FDA classified
July 9, 2026
FDA report date
July 8, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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