FDAFDA · Food and drugs·Recall number D-0225-2026
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
Published December 17, 2025 · Recall initiated: November 14, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CINACALCET
- Manufacturer
- Cipla USA, Inc.
- Distributor
- Nationwide in the US
- Lot
- Lot 5PB0164, exp 1/31/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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