Quick answers
- What is Clindamycin phosphate/benzoyl peroxide/adapalene used for?
- The FDA-approved label (Cabtreo, Bausch Health US LLC, April 24, 2025) says: “CABTREO is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older. CABTREO is a combination of clindamycin phosphate (a lincosamide antibacterial), adapalene (a retinoid), and benzoyl peroxide indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Clindamycin phosphate/benzoyl peroxide/adapalene have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Clindamycin phosphate/benzoyl peroxide/adapalene?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Clindamycin phosphate/benzoyl peroxide/adapalene been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started February 12, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Clindamycin phosphate/benzoyl peroxide/adapalene?
- 1 company lists prescription products of Clindamycin phosphate/benzoyl peroxide/adapalene in the FDA NDC Directory, including Bausch Health US, LLC.
What Clindamycin phosphate/benzoyl peroxide/adapalene is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CABTREO is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older. CABTREO is a combination of clindamycin phosphate (a lincosamide antibacterial), adapalene (a retinoid), and benzoyl peroxide indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.
— FDA label: Cabtreo, Bausch Health US LLC, effective April 24, 2025. Read the full label on DailyMed →
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.
Forms and how it is given
| Dosage forms | Gel |
|---|---|
| Route | Topical |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Cabtreo |
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, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA216632 CABTREO | Bausch | October 20, 2023 | — |
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.
-
February 12, 2024 · Class II · Terminated · D-0347-2024
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g, Distributed by Bausch Health US, LLC Bridgewater, NJ 08807 — MCKESSON CORPORATION
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) | 2668198, 2668204 |
|---|---|
| SPL set ID of the quoted label | 9468da0f-9978-4c58-8135-0274c3415084 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA216632 |
| Active ingredients (FDA) | ADAPALENE / BENZOYL PEROXIDE / CLINDAMYCIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cabtreo, Bausch Health US LLC, effective April 24, 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 →