Quick answers
- What is Carboplatin used for?
- The FDA-approved label (Kyxata, Avyxa Pharma, LLC, September 2, 2025) says: “KYXATA is a platinum-based drug indicated in adults: As part of a combination regimen, for the initial treatment of advanced ovarian carcinoma. As a single-agent for the treatment of ovarian carcinoma recurrent after prior chemotherapy. 1.1 Initial Treatment of Advanced Ovarian Carcinoma KYXATA, as part of a combination regimen, is indicated for the initial treatment of adults with advanced ovarian carcinoma. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Carboplatin have a boxed warning?
- Yes. The FDA label for Kyxata has a boxed warning (“WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Carboplatin?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 21, 2026). Ask your pharmacist about alternatives.
- Has Carboplatin been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started November 8, 2012 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Carboplatin?
- 11 companies list prescription products of Carboplatin in the FDA NDC Directory, including Teva Parenteral Medicines, Inc., Eugia US LLC and Hospira, Inc..
What Carboplatin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
KYXATA is a platinum-based drug indicated in adults: As part of a combination regimen, for the initial treatment of advanced ovarian carcinoma. As a single-agent for the treatment of ovarian carcinoma recurrent after prior chemotherapy. 1.1 Initial Treatment of Advanced Ovarian Carcinoma KYXATA, as part of a combination regimen, is indicated for the initial treatment of adults with advanced ovarian carcinoma. …
— FDA label: Kyxata, Avyxa Pharma, LLC, effective September 2, 2025. Read the full label on DailyMed →
The FDA has 14 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.
This label has a boxed warning. Its heading: WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS
. Read it on the full label →
14 of 14 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 34 in the FDA NDC Directory |
| Brand names | Kyxata |
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.
- Teva Parenteral Medicines, Inc.8 products
- Eugia US LLC6 products
- Hospira, Inc.5 products
- Natco Pharma USA LLC4 products
- BPI Labs LLC4 products
- Teyro Labs Private Limited4 products
- Gland Pharma Limited4 products
- Avyxa Pharma, LLC2 products
- Apotex Corp.1 product
- Fresenius Kabi USA, LLC1 product
- Accord Healthcare Inc.1 product
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 |
|---|---|---|---|
| NDA219921 KYXATA | Avyxa Holdings | August 8, 2025 | — |
Generic approvals (8)
- ANDA076517Hospira · October 14, 2004
- ANDA077269Pharmachemie Bv · October 14, 2004
- ANDA077059Hospira · November 23, 2004
- ANDA077266Fresenius Kabi USA · February 15, 2006
- ANDA077861Teyro Labs · January 18, 2007
- ANDA205487Eugia Pharma · March 28, 2016
- ANDA206775Accord Hlthcare · February 9, 2017
- ANDA207324Gland · February 15, 2017
Shortage status
Current shortage · updated October 21, 2026 · first posted April 28, 2023
| Product | Carboplatin, Injection, 600 mg/60 mL (10 mg/mL) (NDC 61703-600-05) |
|---|---|
| Availability | Unavailable |
| Reason given | Other |
| Company | Hospira, Inc., a Pfizer Company |
Ask your pharmacist whether your product is affected and what the options are.
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.
-
November 8, 2012 · Class I · Terminated · D-154-2013
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, NDC 61703-339-50 (Hospira label) and NDC 61703-360-50 (Novaplus label), Hospira, Inc., Lake Forest, I — Hospira Inc.
-
November 8, 2012 · Class I · Terminated · D-153-2013
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-56. — Hospira Inc.
-
July 2, 2012 · Class III · Terminated · D-1648-2012
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS), b) 45 mL multi-dose vials (NDC 61703-339-50) (NDC 61703-360-50 NOVAPLUS), Rx only, Hospira, Inc., Lake Forest, IL — Hospira Inc.
-
June 27, 2012 · Class II · Terminated · D-1679-2012
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the partic
Carboplatin Injection, 10 mg/mL, 45 mL Multi-Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-50 (Hospira label), NDC 61703-36 — Hospira 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
| RxCUI (RxNorm) | 597195, 2721602 |
|---|---|
| SPL set ID of the quoted label | f91c48da-68d1-4aa7-89b8-d84a3e8b629b |
| FDA labels (SPL) | 14 |
| FDA applications | NDA219921, 8 ANDA |
| Active ingredients (FDA) | CARBOPLATIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Kyxata, Avyxa Pharma, LLC, effective September 2, 2025; 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 →