FDA Drug recall D-0027-2025
Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30
- FDA Drug
- Class II
- ongoing
- Published 2024-11-06
On 2024-11-06 the FDA classified a Class II recall of Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30 by Dr Reddy S Laboratories, citing CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0027-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-09 |
| Published | 2024-11-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
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
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Identifiers
| ndc | 43598-367-30 |
|---|---|
| ndc | 43598-367-05 |
| ndc | 43598-368-30 |
| ndc | 43598-368-05 |
| ndc | 43598-369-30 |
| ndc | 43598-369-05 |
| code_info | Lot# T2200698, Exp 01/2025; T2201444, Exp 03/2025; T2202827, Exp 06/2025; T2300531, Exp 12/2025; T2301696, Exp 02/2026;…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. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0027-2025%22
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