Quick answers
- What is Irinotecan hydrochloride used for?
- The FDA-approved label (Camptosar, Pharmacia & Upjohn Company LLC, May 12, 2026) says: “• CAMPTOSAR is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. • CAMPTOSAR is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. CAMPTOSAR is a topoisomerase inhibitor indicated for …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Irinotecan hydrochloride have a boxed warning?
- Yes. The FDA label for Camptosar has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Irinotecan hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Irinotecan hydrochloride been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started June 11, 2020 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Irinotecan hydrochloride?
- 14 companies list prescription products of Irinotecan hydrochloride in the FDA NDC Directory, including Eugia US LLC, Pharmacia & Upjohn Company LLC and Hikma Pharmaceuticals USA Inc..
What Irinotecan hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
• CAMPTOSAR is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. • CAMPTOSAR is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. CAMPTOSAR is a topoisomerase inhibitor indicated for …
— FDA label: Camptosar, Pharmacia & Upjohn Company LLC, effective May 12, 2026. Read the full label on DailyMed →
The FDA has 16 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. Read it on the full label →
16 of 16 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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.
- Eugia US LLC4 products
- Pharmacia & Upjohn Company LLC3 products
- Hikma Pharmaceuticals USA Inc.3 products
- Qilu Pharmaceutical Co., Ltd.3 products
- NorthStar Rx LLC2 products
- Gland Pharma Limited2 products
- Apotex Corp.2 products
- Xiromed, LLC2 products
- Sagent Pharmaceuticals1 product
- Fresenius Kabi USA, LLC1 product
- BluePoint Laboratories1 product
- Ipsen Biopharmaceuticals, Inc.1 product
- Actavis Pharma, Inc.1 product
- Hospira, 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 |
|---|---|---|---|
| NDA020571 CAMPTOSAR | Pfizer Inc | June 14, 1996 | 35, latest April 4, 2024 2024: Manufacturing (CMC) · 2022: Labeling · 2022: Labeling |
| NDA207793 ONIVYDE | Ipsen | October 22, 2015 | 3, latest December 23, 2024 2024: Labeling · 2024: Efficacy · 2023: Labeling |
Generic approvals (8)
- ANDA077776Fresenius Kabi USA · February 27, 2008
- ANDA077915Hospira · February 27, 2008
- ANDA078589Actavis Totowa · February 27, 2008
- ANDA091032Hikma Farmaceutica · December 20, 2010
- ANDA090675Hengrui Pharma · December 16, 2011
- ANDA203380Qilu Pharm Hainan · May 3, 2016
- ANDA212993Gland · November 18, 2019
- ANDA213278Eugia Pharma · November 2, 2020
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.
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June 11, 2020 · Class II · Terminated · D-1309-2020
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC — Hikma Pharmaceuticals USA Inc.
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June 11, 2020 · Class II · Terminated · D-1308-2020
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC — Hikma Pharmaceuticals USA Inc.
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September 23, 2013 · Class II · Terminated · D-66447-002
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany; Distributed by: West-Ward — West-Ward Pharmaceutical Corp.
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September 23, 2013 · Class II · Terminated · D-66447-001
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany; Distributed by: West-Ward — West-Ward Pharmaceutical Corp.
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January 22, 2013 · Class II · Terminated · D-915-2013
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7. — Fresenius Kabi USA LLC (FK USA)
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) — Camptosar, Pharmacia & Upjohn Company LLC, effective May 12, 2026; 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 →