FDA Drug recall D-0546-2025
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd
- FDA Drug
- Class II
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd by Strides Pharma, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0546-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-09 |
| Published | 2025-08-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Strides Pharma |
| Distribution | US |
Product
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04
Reason
Failed Dissolution Specifications.
Identifiers
| ndc | 64380-883-04 |
|---|---|
| ndc | 64380-884-04 |
| ndc | 64380-885-04 |
| code_info | Lot #: 7715893A, Exp. Date 12/31/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0546-2025%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.