Lanthanum Carbonate Tablets Recalled Due to Failed Stability Test
Cipla USA, Inc. is recalling Lanthanum Carbonate 1000mg chewable tablets (lot NB240314, exp. 12/31/2025) distributed nationwide due to failed hardness testing during stability studies.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II pharmaceutical recall for failed stability specifications on a prescription drug product. While no illnesses or injuries are reported, a failed hardness test represents a risk-of-harm scenario where the tablet's dissolution properties or durability may be compromised, potentially affecting drug efficacy.
Plain-English summary
Cipla USA, Inc. is recalling Lanthanum Carbonate 1000mg chewable tablets due to failed stability specifications, specifically a failed hardness test. The affected lot (NB240314, expiration 12/31/2025) was distributed nationwide.
Lanthanum Carbonate is a phosphate binder prescribed for patients with kidney disease. A failed hardness test during stability studies indicates the tablets may not meet established specifications for durability and dissolution properties, which could affect the tablet's ability to function as intended.
Patients currently taking this medication should not stop without consulting their healthcare provider, as abruptly discontinuing this medication may be medically contraindicated. Patients who have received tablets from lot NB240314 should contact their pharmacy or physician for guidance. No illnesses or injuries have been reported in association with this recall.
The recalled product
- Product
- LANTHANUM CARBONATE (LANTHANUM CARBONATE)
- Brand
- LANTHANUM CARBONATE
- Manufacturer
- Cipla USA, Inc.
- Hazard
- failed-stability-test
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# NB240314
- exp 12/31/2025
UPCs (2)
- 0376282478135
- 0376282476452
Distribution
Distributed nationwide across the United States.
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