FDA Recall D-0044-2025
Cipla USA, Inc. · Warren, NJ
Class II Ongoing 568 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90
Reason for recall
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Recall record
- Recall number
D-0044-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- USA nationwide.
- Recall initiated
- 2024-10-23
- Classified by FDA Center
- 2024-11-12
- FDA published
- 2024-11-20
- Recalling firm
- Cipla USA, Inc.
- Firm location
- Warren, NJ
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.