FDA Drug · D-0675-2026

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

Class II · Ongoing

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

Affected lots / codes — check yours against thisLot #: 5PB0165, 5PB0166, Exp 1/31/2027; 5PB0552, Exp 4/30/2027; 5PB0642, 5PB0643, 5PB0644, Exp 6/30/2027

Recalling firm: Cipla USA, Inc., Warren, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: N/A
Distribution: USA Nationwide
Recall initiated: June 29, 2026
Classified: July 9, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0675-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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