Lanthanum Carbonate chewable tablets recall
FDA recall D-0218-2026 · initiated Oct 24, 2025
Cipla USA, Inc. recalled Lanthanum Carbonate chewable tablets in Oct 2025 — an FDA Class II recall (D-0218-2026) because Failed stability specifications: Out of specification for hardness test.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed stability specifications: Out of specification for hardness test
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
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: N/A
Details
- Product
- Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13.
- Recalling company
- Cipla Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Oct 24, 2025
- FDA report date
- Dec 17, 2025
Frequently asked
- Was Lanthanum Carbonate chewable tablets recalled?
- Cipla USA, Inc. recalled Lanthanum Carbonate chewable tablets in Oct 2025 — an FDA Class II recall (D-0218-2026) because Failed stability specifications: Out of specification for hardness test. 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-0218-2026 was: Failed stability specifications: Out of specification for hardness test
- 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: Nationwide in the USA. The recall covers these lots — Lot# NB240314, exp 12/31/2025. 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-0218-2026.