FDAFDA · Food and drugs·Recall number D-0451-2026
Cinacalcet Hydrochloride Tablets, 90 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: 69097-412-02
Published April 22, 2026 · Recall initiated: March 16, 2026
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; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CINACALCET
- Manufacturer
- Cipla USA, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot, expiry: 4PB0224, exp March-2026; 4PB0505, 4PB0506, 4PB0507, exp September-2026; 5PB0564, exp April-2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.