Cinacalcet Tablets — Class II drug recall D-0027-2025
Ongoing recall by Dr. Reddy's Laboratories, Inc., reported 2024-11-06, distributed nationwide. CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
| Recall number | D-0027-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2024-10-09 |
| Classified | 2024-10-28 |
| Reported by FDA | 2024-11-06 |
| Distributed | Nationwide (US) |
| Quantity | 35,880 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 43598-0367, 43598-0367-05, 43598-0367-30, 43598-0368, 43598-0368-05, 43598-0368-30, 43598-0369, 43598-0369-05, 43598-0369-30 |
| Lot numbers | T2200698, T2201444, T2202827, T2300531, T2301696, T2304726, T2400480 |
| Expiration dates | 2025-01, 2025-03, 2025-06, 2025-12, 2026-02, 2026-08, 2026-11 |
Product
Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.
Reason for recall
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0027-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.