Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
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 USA, Manufactured by: Bausch Health Companies, Inc. Laval Quebec H7L 448, Canada, NDC 0187-0006-25.
Why it was recalled
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
The recall was initiated by MCKESSON CORPORATION (the firm that distributes or relabels it); the product is made by Bausch Health US LLC. That is normal — the distributor, not always the maker, files the recall.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
Lot: 7001796, Exp 05/31/2025
Recall status
Terminated — the FDA has closed the recall; the firm's corrective actions were judged effective.
Where it was distributed
Nationwide in the US
Recall record
- Recalling firm
- MCKESSON CORPORATION
- Manufacturer
- Bausch Health US LLC
- Brand name
- CABTREO
- Generic name
- CLINDAMYCIN PHOSPHATE/BENZOYL PEROXIDE/ADAPALENE
- Product type
- Drugs
- Recall number
- D-0347-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Origin
- IRVING, TX
- Recall initiated
- 2024-02-12
- Terminated
- 2024-10-01
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall D-0347-2024 · Source: openFDA enforcement.