Quick answers
- What is Bexarotene used for?
- The FDA-approved label (Targretin, Bausch Health US, LLC, April 30, 2020) says: “TARGRETIN ® (bexarotene) Capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. TARGRETIN (bexarotene) is a retinoid indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Bexarotene have a boxed warning?
- Yes. The FDA label for Targretin has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Bexarotene?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Bexarotene been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started July 29, 2019 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Bexarotene?
- 8 companies list prescription products of Bexarotene in the FDA NDC Directory, including Bausch Health US, LLC, Amneal Pharmaceuticals NY LLC and Actavis Pharma, Inc..
What Bexarotene is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TARGRETIN ® (bexarotene) Capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. TARGRETIN (bexarotene) is a retinoid indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.
— FDA label: Targretin, Bausch Health US, LLC, effective April 30, 2020. Read the full label on DailyMed →
The FDA has 9 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 →
7 of 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule, liquid filled · Capsule · Gel |
|---|---|
| Route | Oral · Topical |
| Prescription products | 10 in the FDA NDC Directory |
| Brand names | Targretin |
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.
- Bausch Health US, LLC2 products
- Amneal Pharmaceuticals NY LLC2 products
- Actavis Pharma, Inc.1 product
- Upsher-Smith Laboratories, Inc.1 product
- ANI Pharmaceuticals, Inc.1 product
- Mylan Pharmaceuticals Inc.1 product
- Camber Pharmaceuticals, Inc.1 product
- AvKARE1 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 |
|---|---|---|---|
| NDA021055 TARGRETIN | Bausch | December 29, 1999 | 9, latest September 14, 2015 2015: Manufacturing (CMC) · 2015: Efficacy · 2014: Manufacturing (CMC) |
| NDA021056 TARGRETIN | Bausch | June 28, 2000 | 4, latest February 9, 2015 2015: Manufacturing (CMC) · 2013: Manufacturing (CMC) · 2011: Labeling |
Generic approvals (7)
- ANDA203174Bionpharma · August 12, 2014
- ANDA209861Ani Pharms · May 8, 2018
- ANDA209886Upsher Smith Labs · July 25, 2018
- ANDA210105Amneal Pharms Ny · September 4, 2018
- ANDA209931Teva Pharms USA · January 14, 2021
- ANDA215398Amneal · April 27, 2022
- ANDA208628Ascent Pharms Inc · September 6, 2024
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.
-
July 29, 2019 · Class II · Terminated · D-1836-2019
Failed Dissolution Specifications
Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Grove, MN 55369. NDC: 0832-0285-00 — Upsher Smith 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) | 261349, 308724, 308725, 991233 |
|---|---|
| SPL set ID of the quoted label | 1d056725-0576-4338-8089-6336e768ccdc |
| FDA labels (SPL) | 9 |
| FDA applications | NDA021055, NDA021056, 7 ANDA |
| Active ingredients (FDA) | BEXAROTENE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Targretin, Bausch Health US, LLC, effective April 30, 2020; 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 →