Cinacalcet Hydrochloride Tablets 30 mg — Class II drug recall D-0278-2025
Completed recall by Slate Run Pharmaceuticals, reported 2025-03-26, distributed nationwide. CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
| Recall number | D-0278-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Slate Run Pharmaceuticals, Columbus, OH, United States |
| Recall initiated | 2025-03-07 |
| Classified | 2025-03-17 |
| Reported by FDA | 2025-03-26 |
| Distributed | Nationwide (US) |
| Quantity | 56,790 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 70436-0007-04 |
| Lot numbers | 07711, 08899, 08900 |
| Expiration dates | 2025-07, 2026-09 |
Product
Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04
Reason for recall
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake 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-0278-2025. 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.