FDA Drug recall D-0217-2026
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-0217-2026 |
| 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., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98.
Reason
Failed stability specifications: Out of specification for hardness test
Identifiers
| ndc | 69097-934-57 |
|---|---|
| ndc | 69097-934-98 |
| ndc | 69097-935-89 |
| ndc | 69097-935-98 |
| ndc | 69097-936-65 |
| ndc | 69097-936-98 |
| code_info | lot# NB240315, 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-0217-2026%22
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