FDA recall D-0513-2025

KABANA SKIN CARE · Class II · drug

Product

Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per bottle, Made in USA for Erin's Faces, Millburn, NO 07041. NDC: 73369-1401-1

Reason for recall

cGMP deviations

Distribution

NJ, FL, MI

Key facts

Status
Ongoing
Initiation date
2025-03-12
Report date
2025-07-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Louisville, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0513-2025