Quick answers
- What is Docetaxel used for?
- The FDA-approved label (Beizray, Zydus Pharmaceuticals USA Inc., December 17, 2025) says: “BEIZRAY is a microtubule inhibitor indicated for: Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Docetaxel have a boxed warning?
- Yes. The FDA label for Beizray has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Docetaxel?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Docetaxel been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started May 28, 2024 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Docetaxel?
- 22 companies list prescription products of Docetaxel in the FDA NDC Directory, including Hospira, Inc., Mylan Institutional LLC and Baxter Healthcare Corporation.
What Docetaxel is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
BEIZRAY is a microtubule inhibitor indicated for: Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure …
— FDA label: Beizray, Zydus Pharmaceuticals USA Inc., effective December 17, 2025. Read the full label on DailyMed →
The FDA has 29 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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 →
29 of 29 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.
- Hospira, Inc.11 products
- Mylan Institutional LLC7 products
- Baxter Healthcare Corporation6 products
- Dr. Reddy's Laboratories Inc.5 products
- Gland Pharma Limited3 products
- Sun Pharmaceutical Industries, Inc.3 products
- Eugia US LLC3 products
- Amneal Pharmaceuticals LLC3 products
- Meitheal Pharmaceuticals Inc.3 products
- Avyxa Pharma, LLC3 products
- Jiangsu Hengrui Pharmaceuticals Co., Ltd.3 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.3 products
- Sanofi-Aventis U.S. LLC3 products
- Sagent Pharmaceuticals2 products
- Zhuhai Beihai Biotech Co., Ltd.2 products
- Zydus Pharmaceuticals USA Inc.2 products
- Actavis Pharma, Inc.2 products
- Hikma Pharmaceuticals USA Inc.2 products
- Alembic Pharmaceuticals Limited1 product
- Alembic Pharmaceuticals Inc.1 product
- Accord Healthcare Inc.1 product
- Sandoz Inc1 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 |
|---|---|---|---|
| NDA020449 TAXOTERE | Sanofi Aventis Us | May 14, 1996 | 51, latest January 18, 2023 2023: Labeling · 2022: Labeling · 2020: Labeling |
| NDA022234 DOCETAXEL | Hospira Inc | March 8, 2011 | 12, latest May 15, 2023 2023: Labeling · 2020: Labeling · 2019: Labeling |
| NDA022534 DOCEFREZ, DOCETAXEL | Sun Pharm | May 3, 2011 | 10, latest August 22, 2023 2023: Labeling · 2022: Labeling · 2021: Labeling |
| NDA201195 DOCETAXEL | Accord Hlthcare | June 8, 2011 | 9, latest September 20, 2023 2023: Labeling · 2020: Labeling · 2019: Labeling |
| NDA201525 DOCETAXEL | Sandoz | June 29, 2011 | 13, latest September 21, 2023 2023: Labeling · 2021: Labeling · 2020: Labeling |
| NDA203551 DOCETAXEL | Actavis | April 12, 2013 | 8, latest August 26, 2024 2024: Labeling · 2020: Labeling · 2019: Labeling |
| NDA215813 DOCETAXEL, DOCIVYX | Avyxa Holdings | November 22, 2022 | 3, latest January 17, 2025 2025: Manufacturing (CMC) · 2024: Labeling · 2024: Labeling |
| NDA218711 BEIZRAY | Zhuhai | October 23, 2024 | 1, latest April 22, 2025 2025: Labeling |
Generic approvals (14)
- ANDA204193DR Reddys · November 5, 2014
- ANDA207252Hengrui Pharma · August 9, 2017
- ANDA209640Amneal · January 19, 2018
- ANDA208859Mylan Labs Ltd · April 30, 2018
- ANDA210072Mylan Labs Ltd · July 2, 2018
- ANDA210848Mylan Labs Ltd · July 6, 2018
- ANDA209634Meitheal · August 24, 2018
- ANDA208137Mylan Labs Ltd · April 1, 2019
- ANDA204490Hikma · January 14, 2021
- ANDA214575Eugia Pharma · June 25, 2021
- ANDA213510Gland · July 1, 2021
- ANDA215744Alembic · February 28, 2023
- ANDA216677Heritage · February 28, 2024
- ANDA213768Guangdong Sunho · May 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.
-
May 28, 2024 · Class I · Ongoing · D-0554-2024
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08 — Sagent Pharmaceuticals
-
May 28, 2024 · Class I · Ongoing · D-0553-2024
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08 — Sagent Pharmaceuticals
-
March 6, 2019 · Class II · Terminated · D-1001-2019
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, Andhra Pradesh, INDIA, NDC 43598-259-40. — Dr. Reddy's Laboratories, Inc.
-
April 27, 2018 · Class II · Terminated · D-0804-2018
Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01 — Sanofi-Aventis U.S. LLC
-
January 9, 2017 · Class II · Terminated · D-0213-2018
Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off.
Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046 INDIA, NDC 43598-611-11 — Dr. Reddy's Laboratories, 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) | 1001405, 1093280, 1860480, 1860485, 1860619, 1861411, 2054168, 2054170, 2679779, 2679784 … (+9) |
|---|---|
| SPL set ID of the quoted label | 8fb7d980-d6c7-468b-a9f0-adff16101a4b |
| FDA labels (SPL) | 29 |
| FDA applications | NDA020449, NDA022234, NDA022534, NDA201195, NDA201525, NDA203551, NDA215813, NDA218711, 14 ANDA |
| Active ingredients (FDA) | DOCETAXEL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Beizray, Zydus Pharmaceuticals USA Inc., effective December 17, 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 →