Cinacalcet Tablets 90 mg — Class II drug recall D-0546-2025
Ongoing recall by Strides Pharma, Inc., reported 2025-08-06, distributed nationwide. Failed Dissolution Specifications.
| Recall number | D-0546-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Strides Pharma, Inc., Chestnut Ridge, NY, United States |
| Recall initiated | 2025-07-09 |
| Classified | 2025-07-30 |
| Reported by FDA | 2025-08-06 |
| Distributed | Nationwide (US) |
| Quantity | 6,672 bottles |
| Reason classes | specification failure |
| NDC | 64380-0883, 64380-0883-04, 64380-0884, 64380-0884-04, 64380-0885, 64380-0885-04 |
| Lot numbers | 7715893A |
| Expiration dates | 2027-12-31 |
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 for recall
Failed Dissolution Specifications.
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-0546-2025. 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.