Cinacalcet Tablets 30 mg — Class II drug recall D-0030-2025
Ongoing recall by ACCORD HEALTHCARE, INC., reported 2024-11-06, distributed nationwide. CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily inta
| Recall number | D-0030-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ACCORD HEALTHCARE, INC., Raleigh, NC, United States |
| Recall initiated | 2024-10-10 |
| Classified | 2024-10-31 |
| Reported by FDA | 2024-11-06 |
| Distributed | Nationwide (US) |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 16729-0440, 16729-0440-01, 16729-0440-10, 16729-0440-15, 16729-0441, 16729-0441-01, 16729-0441-10, 16729-0441-15, 16729-0442, 16729-0442-01, 16729-0442-10, 16729-0442-15 |
| Lot numbers | M2118190, M2201091, M2206241, M2206451, M2208674, M2210808, M2212212, M2213850, M2214435, M2215221, M2216236, M2217097, M2217098, M2300664, M2301921 |
Product
Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.
Reason for recall
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
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-0030-2025. 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.