⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Cipla USA, Inc.: Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: C

DrugsSource: FDA (drug) · Date: 2026-07-08

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Cipla USA, Inc.
Product
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
Reason / hazard
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Classification
Class II
Status
Ongoing
Distribution / sold at
USA Nationwide
Recall initiated
2026-06-29
Code info
Lot #: 5PB0165, 5PB0166, Exp 1/31/2027; 5PB0552, Exp 4/30/2027; 5PB0642, 5PB0643, 5PB0644, Exp 6/30/2027
Product quantity
N/A
Voluntary mandated
Voluntary: Firm initiated
City
Warren
State
NJ
Country
United States
Event id
99350
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