Class II
Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- Recall number
- D-0027-2025
- Report date
- November 6, 2024
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Generic names
- CINACALCET
- Brand names
- CINACALCET
- Product NDCs
- 43598-367, 43598-368, 43598-369
Code and lot information
Lot# T2200698, Exp 01/2025; T2201444, Exp 03/2025; T2202827, Exp 06/2025; T2300531, Exp 12/2025; T2301696, Exp 02/2026; T2304726, Exp 08/2026; T2400480, Exp 11/2026.
Distribution
USA Nationwide.
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.