# FDA recall D-0032-2025

> **ACCORD HEALTHCARE, INC.** · Class II · drug recall initiated 2024-10-10.

## Product

Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, 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.

## Distribution

Nationwide in the USA and PR

## Key facts

- **Recall number:** D-0032-2025
- **Recalling firm:** ACCORD HEALTHCARE, INC.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-10-10
- **Report date:** 2024-11-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Raleigh, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0032-2025

## Citation

> AI Analytics. FDA recall D-0032-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0032-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*