FDA Recall D-0546-2025
Strides Pharma, Inc. · Chestnut Ridge, NY
Class II Ongoing 309 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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.
Recall record
- Recall number
D-0546-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Product was distributed nationwide within the United States
- Recall initiated
- 2025-07-09
- Classified by FDA Center
- 2025-07-30
- FDA published
- 2025-08-06
- Recalling firm
- Strides Pharma, Inc.
- Firm location
- Chestnut Ridge, NY
Drug identification
- Brand name(s)
- CINACALCET
- Generic name(s)
- CINACALCET
- Manufacturer(s)
- Strides Pharma Science Limited
- NDC(s)
64380-883, 64380-884, 64380-885- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.