Cinacalcet Tablets — Class II drug recall D-0077-2025
Ongoing recall by Aurobindo Pharma USA Inc, reported 2024-12-11, distributed nationwide. cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
| Recall number | D-0077-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc, East Windsor, NJ, United States |
| Recall initiated | 2024-11-07 |
| Classified | 2024-11-29 |
| Reported by FDA | 2024-12-11 |
| Distributed | Nationwide (US) |
| Quantity | 102,576 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 65862-0831-05, 65862-0831-30 |
| Expiration dates | 2024-12-31, 2025-03-31, 2025-07-31, 2025-10-31 |
Product
Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
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-0077-2025. 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.