Lanthanum Carbonate tablets recalled nationwide for failed stability test
Cipla USA is recalling Lanthanum Carbonate tablets (1000mg) due to failed stability specifications in hardness testing. The recall affects 1,180 boxes of lot NB240315 distributed nationwide.
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 classification indicates potential for adverse health consequences from a failed medication stability test. The tablets being out of specification for hardness represents a risk-of-harm to patients, though no illnesses or injuries have been reported.
Plain-English summary
Cipla USA, Inc. is recalling Lanthanum Carbonate chewable tablets (1000 mg) due to failed stability specifications. Approximately 1,180 boxes of lot number NB240315 (expiration December 31, 2025) were distributed nationwide.
The tablets were found to be out of specification for hardness testing, a component of stability testing for medications. Lanthanum carbonate is a prescription medication used to control phosphorus levels in patients with chronic kidney disease.
Patients who have obtained tablets from lot NB240315 should discontinue use and contact their healthcare provider or pharmacist for guidance on this recall.
The recalled product
- Product
- LANTHANUM CARBONATE (LANTHANUM CARBONATE)
- Brand
- LANTHANUM CARBONATE
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug — Prescription
- Hazard
- stability-failure
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# NB240315
- exp 12/31/2025
UPCs (3)
- 0369097935894
- 0369097936655
- 0369097934576
Distribution
Distributed nationwide across the United States.
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