Cipla Usa, Inc.: Cinacalcet Hydrochloride Tablets, 90 Mg, 30-count Bottle
Recall Summary Cipla USA is recalling Cinacalcet Hydrochloride Tablets 90 mg (30-count bottles) distributed nationwide because the tablets contain elevated levels of N-nitroso-cinacalcet, a impurity that exceeds acceptable safety limits. Cinacalcet is a prescription medication used to treat high calcium levels in patients with certain kidney and parathyroid conditions. The recall affects products distributed across all U.S. states and Washington, D.C.
- Recalling firm
- Cipla USA, Inc.
- Product
- 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
- Reason
- cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-06-29
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- USA Nationwide
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/2446c84f-f17a-4ba4-8cc8-8ce35ebb5272