Class II
Ongoing
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
This recall is currently active, issued December 17, 2025. It was issued by Cipla Usa, Inc..
- Company
- Cipla Usa, Inc.
- Recall Initiated
- November 14, 2025
- Posted
- December 17, 2025
- Recall Number
- D-0224-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 63,504 bottles
- Firm Location
- Warren, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Distribution
Nationwide in the US
Lot / Code Info
Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027
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