CLASS II ONGOING Drug recall · Reported 7 Feb 2024 · FDA Enforcement Report
OralProCare medicated lip treatment recalled by Den-Mat Holdings
Den-Mat Holdings is recalling OralProCare medicated lip treatment, distributed nationwide in the US. The recall was initiated on 16 Jan 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0286-2024
- FDA event ID
- 93831
- Recalling firm
- Den-Mat Holdings, Lompoc, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Jan 2024
- FDA classified
- 31 Jan 2024
- Reported
- 7 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 16 Jan 2024 | Recall initiated by company | |
| 31 Jan 2024 | Classified by FDA | +15 days |
| 7 Feb 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: products may not conform to the labeled specifications.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
CGMP Deviations: products may not conform to the labeled specifications.
Which lots are affected?
Lot #s: 2319500023, Exp: 01- 12-2024; 2330400002, Exp: 11-02-2024.
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 93831This product is part of a recall event; the main page for the event is Hydrogen Peroxide Oral Rinse recalled by Den-Mat Holdings.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Hydrogen Peroxide Oral Rinse recalled by Den-Mat Holdings | Den-Mat Holdings | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Den-Mat Holdings
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydrogen Peroxide Oral Rinse recalled by Den-Mat Holdings | Den-Mat Holdings | Manufacturing (CGMP) Deviations | Nationwide |