The U.S. Food and Drug Administration (FDA) announced a voluntary nationwide recall of Cinacalcet Hydrochloride Tablets, 90 mg, manufactured for Cipla USA, Inc., due to current Good Manufacturing Practice (CGMP) deviations.
The affected product was found to contain levels of a nitrosamine impurity, N-nitroso-cinacalcet, exceeding the acceptable daily intake (ADI) limits.
The recall involves 12,576 bottles from lot 5PB0183, with an expiration date of January 31, 2027, distributed nationwide across the United States. The prescription-only medication is marketed under NDC 69097-412-02.
The FDA has classified the recall as Class II, indicating that use of the product may cause temporary or medically reversible adverse health effects.
The recall was voluntarily initiated by the company on November 14, 2026, and the action remains ongoing. No public press release has been issued in connection with this recall at this time.
