Official recall notice
FDA DrugClass IINotable
FDA Recall: Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC
- Recall date
- 2026-07-08
- Brand
- Cipla USA, Inc.
- Category
- Drug
- FDA class
- Class II
Why it was recalled
Hazard
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Product description
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Affected products
Lot #: 5PB0165, 5PB0166, Exp 1/31/2027; 5PB0552, Exp 4/30/2027; 5PB0642, 5PB0643, 5PB0644, Exp 6/30/2027