FDA Drug recall D-0218-2026
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc…
- FDA Drug
- Class II
- ongoing
- Published 2025-12-17
On 2025-12-17 the FDA classified a Class II recall of Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc… by Cipla Usa, citing failed stability specifications: Out of specification for hardness test.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0218-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-24 |
| Published | 2025-12-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cipla Usa |
| Distribution | US |
Product
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13.
Reason
Failed stability specifications: Out of specification for hardness test
Identifiers
| ndc | 76282-476-45 |
|---|---|
| ndc | 76282-476-90 |
| ndc | 76282-477-15 |
| ndc | 76282-477-90 |
| ndc | 76282-478-13 |
| ndc | 76282-478-90 |
| code_info | Lot# NB240314, exp 12/31/2025 |
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-0218-2026%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.