Lanthanum Carbonate chewable tablets — Class II drug recall D-0217-2026
Ongoing recall by Cipla USA, Inc., reported 2025-12-17, distributed nationwide. Failed stability specifications: Out of specification for hardness test
| Recall number | D-0217-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cipla USA, Inc., Warren, NJ, United States |
| Recall initiated | 2025-10-24 |
| Classified | 2025-12-05 |
| Reported by FDA | 2025-12-17 |
| Distributed | Nationwide (US) |
| Quantity | 1,180 boxes |
| Reason classes | specification failure |
| NDC | 69097-0934, 69097-0934-57, 69097-0934-98, 69097-0935, 69097-0935-89, 69097-0935-98, 69097-0936, 69097-0936-65, 69097-0936-98 |
| Lot numbers | NB240315 |
| Expiration dates | 2025-12-31 |
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 for recall
Failed stability specifications: Out of specification for hardness test
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-0217-2026. 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.