Quick answers
- What is Azelaic acid used for?
- The FDA-approved label (Azelex, Almirall, LLC, March 4, 2024) says: “AZELEX ® cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Azelaic acid have a boxed warning?
- No. None of the 8 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Azelaic acid?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Azelaic acid been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started July 23, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Azelaic acid?
- 8 companies list prescription products of Azelaic acid in the FDA NDC Directory, including Actavis Pharma, Inc., Encube Ethicals, Inc. and LEO Pharma Inc..
What Azelaic acid is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
AZELEX ® cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris.
— FDA label: Azelex, Almirall, LLC, effective March 4, 2024. Read the full label on DailyMed →
The FDA has 8 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 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Gel · Aerosol, foam · Cream |
|---|---|
| Route | Topical · Cutaneous |
| Prescription products | 8 in the FDA NDC Directory |
| Brand names | Finacea Foam, Azelex |
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 |
|---|---|---|
| azelaic acid 15% aerosol, foam | Brand: Finacea Foam | $8.34 per gram |
| azelaic acid 15% gel | Generic | $0.4604 per gram |
NADAC list of November 4, 2026; these prices took effect on 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.
- Actavis Pharma, Inc.1 product
- Encube Ethicals, Inc.1 product
- LEO Pharma Inc.1 product
- Bryant Ranch Prepack1 product
- Glenmark Pharmaceuticals Inc., USA1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Sandoz Inc1 product
- Almirall, LLC1 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 |
|---|---|---|---|
| NDA020428 AZELEX | Almirall | September 13, 1995 | 16, latest February 20, 2024 2024: Manufacturing (CMC) · 2020: Labeling · 2003: Labeling |
| NDA021470 FINACEA | Leo Pharma As | December 24, 2002 | 11, latest November 1, 2021 2021: Labeling · 2020: Labeling · 2020: Labeling |
| NDA207071 FINACEA | Leo Pharma As | July 29, 2015 | 2, latest December 1, 2020 2020: Labeling · 2020: Labeling |
Generic approvals (4)
- ANDA204637Glenmark Speclt · November 19, 2018
- ANDA208011Actavis Labs Ut Inc · November 19, 2018
- ANDA208724Encube · November 19, 2018
- ANDA210549Sun Pharma Canada · August 23, 2019
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 23, 2026 · Class II · Ongoing · D-0731-2026
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52. — Glenmark Pharmaceuticals Inc., USA
-
September 17, 2025 · Class II · Ongoing · D-0662-2025
CGMP Deviations: Market complaints received for gritty texture (grainy)
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, — Glenmark Pharmaceuticals Inc., USA
-
July 22, 2024 · Class II · Ongoing · D-0621-2024
CGMP Deviations
Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 6846 — Glenmark Pharmaceuticals Inc., 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) — Azelex, Almirall, LLC, effective March 4, 2024; 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 →