CABTREO (clindamycin phosphate recall
FDA recall D-0347-2024 · initiated Feb 12, 2024
MCKESSON CORPORATION recalled CABTREO (clindamycin phosphate in Feb 2024 — an FDA Class II recall (D-0347-2024) because CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
May cause temporary or medically reversible harm; low probability of serious harm.
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.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 42 units
Details
- Product
- 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.
- Recalling company
- MCKESSON CORPORATION
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- Feb 12, 2024
- FDA report date
- Feb 28, 2024
This recall is linked to a product we cover: Cabtreo →
Frequently asked
- Was CABTREO (clindamycin phosphate recalled?
- MCKESSON CORPORATION recalled CABTREO (clindamycin phosphate in Feb 2024 — an FDA Class II recall (D-0347-2024) because CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was CABTREO (clindamycin phosphate recalled?
- Per the FDA enforcement record, the reason for recall D-0347-2024 was: CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
- Is a recalled CABTREO (clindamycin phosphate dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of CABTREO (clindamycin phosphate are affected?
- Distributed: Nationwide in the US. The recall covers these lots — Lot: 7001796, Exp 05/31/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0347-2024.