FDA Recall D-0513-2025
KABANA SKIN CARE · Louisville, CO
Class II Ongoing 428 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Recall record
- Recall number
D-0513-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- NJ, FL, MI
- Recall initiated
- 2025-03-12
- Classified by FDA Center
- 2025-07-10
- FDA published
- 2025-07-16
- Recalling firm
- KABANA SKIN CARE
- Firm location
- Louisville, CO
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.