Cipla Usa, Inc.: Cinacalcet Hydrochloride Tablets, 30 Mg, 30-count Bottle
Cipla USA is recalling Cinacalcet Hydrochloride Tablets (30 mg, 30-count bottles) distributed nationwide because the medication contains higher-than-acceptable levels of a substance called N-nitroso-cinacalcet, which resulted from manufacturing deviations. This recall affects all U.S. states and territories. Cinacalcet is a prescription medication used to treat certain kidney and parathyroid conditions.
- Recalling firm
- Cipla USA, Inc.
- Product
- Cinacalcet Hydrochloride Tablets, 30 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 69097-410-02
- 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/7fa412f7-b611-41d5-a34d-2ed6547cce3d