RecallRadar

FDA Drug recall D-0286-2024

OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC,…

On 2024-02-07 the FDA classified a Class II recall of OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC,… by Den Mat Holdings, citing CGMP Deviations: products may not conform to the labeled specifications.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0286-2024
ClassificationClass II
Statusongoing
Initiated2024-01-16
Published2024-02-07
Last updated2026-09-13 11:52 UTC
CompanyDen Mat Holdings
DistributionUS

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.

Reason

CGMP Deviations: products may not conform to the labeled specifications.

Identifiers

upc359883000004
code_infoLot #s: 2319500023, Exp: 01- 12-2024; 2330400002, Exp: 11-02-2024.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0286-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.