FDA Drug recall D-0278-2025
Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal…
- FDA Drug
- Class II
- completed
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class II recall of Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal… by Slate Run Pharmaceuticals, citing CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0278-2025 |
| Classification | Class II |
| Status | completed |
| Initiated | 2025-03-07 |
| Published | 2025-03-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Slate Run Pharmaceuticals |
| Distribution | US |
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
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Identifiers
| code_info | Lot # 07711, Exp 07/2025; 08900, Exp 09/2026; 08899, Exp 09/2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0278-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.