Lanthanum Carbonate Chewable Tablets recall
FDA recall D-0043-2025 · initiated Oct 23, 2024
Cipla USA, Inc. recalled Lanthanum Carbonate Chewable Tablets in Oct 2024 — an FDA Class II recall (D-0043-2025) because Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1,875 boxes (cipla and exlan)
Details
- Product
- Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98
- Recalling company
- Cipla Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA nationwide.
- Initiated
- Oct 23, 2024
- FDA report date
- Nov 20, 2024
Frequently asked
- Was Lanthanum Carbonate Chewable Tablets recalled?
- Cipla USA, Inc. recalled Lanthanum Carbonate Chewable Tablets in Oct 2024 — an FDA Class II recall (D-0043-2025) because Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Lanthanum Carbonate Chewable Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0043-2025 was: Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
- Is a recalled Lanthanum Carbonate Chewable Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Lanthanum Carbonate Chewable Tablets are affected?
- Distributed: USA nationwide.. The recall covers these lots — Lot # NB240316, Exp 12/31/25. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0043-2025.