Quick answers
- What is Lanthanum carbonate used for?
- The FDA-approved label (Fosrenol, Takeda Pharmaceuticals America, Inc., December 31, 2024) says: “FOSRENOL ® is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lanthanum carbonate have a boxed warning?
- No. None of the 7 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Lanthanum carbonate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Lanthanum carbonate been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started October 24, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Lanthanum carbonate?
- 7 companies list prescription products of Lanthanum carbonate in the FDA NDC Directory, including Takeda Pharmaceuticals America, Inc., Cipla USA Inc. and Ascend Laboratories, LLC.
What Lanthanum carbonate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
FOSRENOL ® is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders. …
— FDA label: Fosrenol, Takeda Pharmaceuticals America, Inc., effective December 31, 2024. Read the full label on DailyMed →
The FDA has 7 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, chewable · Powder |
|---|---|
| Route | Oral |
| Prescription products | 23 in the FDA NDC Directory |
| Brand names | Fosrenol |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| lanthanum carbonate 1000 mg tablet, chewable | Generic | $3.11 per tablet |
| lanthanum carbonate 500 mg tablet, chewable | Generic | $3.12 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Takeda Pharmaceuticals America, Inc.5 products
- Cipla USA Inc.3 products
- Ascend Laboratories, LLC3 products
- Exelan Pharmaceuticals Inc.3 products
- Lupin Pharmaceuticals, Inc.3 products
- Teva Pharmaceuticals USA, Inc.3 products
- Prasco Laboratories3 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021468 FOSRENOL | Takeda Pharms USA | October 26, 2004 | 16, latest August 29, 2024 2024: Labeling · 2023: Labeling · 2023: Labeling |
| NDA204734 FOSRENOL | Takeda Pharms USA | September 24, 2014 | 6, latest August 29, 2024 2024: Labeling · 2023: Labeling · 2023: Labeling |
Generic approvals (4)
- ANDA090978Natco Pharma Ltd · August 11, 2017
- ANDA206868Invagen Pharms · January 24, 2022
- ANDA090977Barr · January 27, 2022
- ANDA202329Alkem Labs Ltd · March 13, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
October 24, 2025 · Class II · Ongoing · D-0217-2026
Failed stability specifications: Out of specification for hardness test
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boule — Cipla USA, Inc.
-
October 24, 2025 · Class II · Ongoing · D-0218-2026
Failed stability specifications: Out of specification for hardness test
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 Pharm — Cipla USA, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Fosrenol, Takeda Pharmaceuticals America, Inc., effective December 31, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →