OralProCare medicated lip treatment recall
FDA recall D-0286-2024 · initiated Jan 16, 2024
Den-Mat Holdings, LLC recalled OralProCare medicated lip treatment in Jan 2024 — an FDA Class II recall (D-0286-2024) because CGMP Deviations: products may not conform to the labeled specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: products may not conform to the labeled specifications.
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: 344 tubes
Details
- Product
- OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000 4.
- Recalling company
- Den-Mat
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- Jan 16, 2024
- FDA report date
- Feb 7, 2024
Frequently asked
- Was OralProCare medicated lip treatment recalled?
- Den-Mat Holdings, LLC recalled OralProCare medicated lip treatment in Jan 2024 — an FDA Class II recall (D-0286-2024) because CGMP Deviations: products may not conform to the labeled specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was OralProCare medicated lip treatment recalled?
- Per the FDA enforcement record, the reason for recall D-0286-2024 was: CGMP Deviations: products may not conform to the labeled specifications.
- Is a recalled OralProCare medicated lip treatment 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 OralProCare medicated lip treatment are affected?
- Distributed: Nationwide in the US. The recall covers these lots — Lot #s: 2319500023, Exp: 01- 12-2024; 2330400002, Exp: 11-02-2024.. 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-0286-2024.