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

Cipla USA, Inc.: Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite

DrugsSource: FDA (drug) · Date: 2025-12-17

Read the official notice at FDA (drug) →

Share on XFacebookRedditEmail

Get alerts for Cipla

Guides: Which agency handles which recall (FDA vs USDA vs CPSC vs NHTSA)

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, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
Reason / hazard
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide in the US
Recall initiated
2025-11-14
Code info
Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027
Product quantity
63,504 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Warren
State
NJ
Country
United States
Event id
97974
Free daily digest + "My products" watchlist

Get the daily digest, and tell us what to watch. Everything is optional except your email.

Free allergen alerts:

Categories:

Privacy: we store only what you enter here, use it only to send recall alerts you asked for, never sell or share it, and you can unsubscribe anytime. Double opt-in: we will email you a confirmation link before sending anything; alerts start only after you confirm. Every email has unsubscribe and manage-watchlist links.