Quick answers
- What is Tazarotene used for?
- The FDA-approved label (Tazorac, Almirall, LLC, November 13, 2025) says: “TAZORAC ® Gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. TAZORAC Gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. Limitations of Use The safety of TAZORAC Gel use on more than 20% body surface area has not been established. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tazarotene have a boxed warning?
- No. None of the 16 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Tazarotene?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tazarotene been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started March 21, 2018 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Tazarotene?
- 10 companies list prescription products of Tazarotene in the FDA NDC Directory, including Almirall, LLC, Cosette Pharmaceuticals, Inc. and Padagis Israel Pharmaceuticals Ltd.
What Tazarotene is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TAZORAC ® Gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. TAZORAC Gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. Limitations of Use The safety of TAZORAC Gel use on more than 20% body surface area has not been established. …
— FDA label: Tazorac, Almirall, LLC, effective November 13, 2025. 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.
The label quoted above has no boxed warning.
0 of 16 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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 |
|---|---|---|
| tazarotene 0.05% cream | Generic | $7.23–$8.06 per gram 4 packages, lowest to highest |
| tazarotene 0.05% gel | Generic | $5.92 per gram |
| tazarotene 0.1% aerosol, foam | Brand: Fabior | $12.32 per gram |
| tazarotene 0.1% cream | Generic | $1.77–$1.91 per gram 5 packages, lowest to highest |
| tazarotene 0.1% gel | Generic | $5.71–$6.35 per gram 6 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect between June 17, 2026 and 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.
- Almirall, LLC4 products
- Cosette Pharmaceuticals, Inc.4 products
- Padagis Israel Pharmaceuticals Ltd3 products
- Mayne Pharma2 products
- Solaris Pharma Corporation2 products
- Bryant Ranch Prepack2 products
- Sun Pharmaceutical Industries, Inc.2 products
- Mayne Pharma Inc.1 product
- Bausch Health US, LLC1 product
- Perfero Pharma, 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 |
|---|---|---|---|
| NDA020600 TAZORAC | Chartwell Rx | June 13, 1997 | 7, latest April 16, 2018 2018: Labeling · 2017: Labeling · 2011: Labeling |
| NDA021184 AVAGE, TAZORAC | Chartwell Rx | September 29, 2000 | 5, latest July 21, 2017 2017: Labeling · 2016: Labeling · 2013: Labeling |
| NDA202428 FABIOR | Mayne Pharma | May 11, 2012 | — |
| NDA211882 ARAZLO | Bausch | December 18, 2019 | — |
Generic approvals (7)
- ANDA208258Sun Pharma Canada · April 3, 2017
- ANDA208662Cosette Pharms Nc · December 22, 2017
- ANDA214136Cosette Pharms Nc · September 13, 2022
- ANDA215433Cosette Pharms Nc · September 13, 2022
- ANDA213644Solaris Pharma Corp · March 20, 2023
- ANDA213079Padagis Israel · April 25, 2023
- ANDA217075Padagis Israel · July 15, 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.
-
March 21, 2018 · Class III · Terminated · D-0616-2018
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10. — Mayne Pharma 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) — Tazorac, Almirall, LLC, effective November 13, 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 →