Class II
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- Recall number
- D-0225-2026
- Report date
- December 17, 2025
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Cipla USA, Inc.
- Generic names
- CINACALCET
- Brand names
- CINACALCET
- Product NDCs
- 69097-410, 69097-411, 69097-412
Code and lot information
Lot 5PB0164, exp 1/31/2027
Distribution
Nationwide in the US
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.