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

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

DrugsSource: FDA (drug) · Date: 2026-04-22

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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 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: 69097-411-02
Reason / hazard
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide in the USA
Recall initiated
2026-03-16
Code info
Lot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027
Product quantity
96,096 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Warren
State
NJ
Country
United States
Event id
98670
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