Lanthanum carbonate tablets recalled in a second hardness specification failure
Cipla USA is recalling 1,180 boxes of Lanthanum Carbonate chewable tablets, 1000mg, from a further lot after an out of specification hardness test result.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites an out of specification stability result with no stated clinical consequence or reported harm.
Plain-English summary
Lanthanum Carbonate chewable tablets, 1000mg, supplied as 10 x 9 bottles per patient pack carton, are being recalled. The prescription product is manufactured by Invagen Pharmaceuticals, Inc. of Hauppauge, New York, for Cipla USA, Inc. of Warren, New Jersey.
The recall follows failed stability specifications: an out of specification result on the hardness test.
This record covers 1,180 boxes from lot NB240315, expiry 12/31/2025. Distribution was nationwide in the USA. The FDA has classified the action as Class II.
The record describes a stability testing failure rather than a reported patient harm. Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific pack is affected.
The recalled product
- Product
- LANTHANUM CARBONATE (LANTHANUM CARBONATE)
- Brand
- LANTHANUM CARBONATE
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug — Phosphate binder
- Affected units
- 1,180
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.
Part of a larger recall action
This product is one of 2 recalled by Cipla USA, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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