FDA recall D-0195-2026
CA BOTANA International, Inc. · Class II · drug
Product
CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17
Reason for recall
CGMP Deviations
Distribution
CA, CO, FL, PR, WA
Key facts
- Status
- Ongoing
- Initiation date
- 2025-10-10
- Report date
- 2025-12-03
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- San Diego, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0195-2026