FDAFDA · Food and drugs·Recall number D-0676-2026
Cinacalcet Hydrochloride Tablets, 90 mg, 30-count 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 July 8, 2026 · Recall initiated: June 29, 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 of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CINACALCET
- Manufacturer
- Cipla USA, Inc.
- Distributor
- USA Nationwide
- Lot
- Lot #: 5PB0563, Exp 4/30/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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