FDA recall D-0190-2026

CA BOTANA International, Inc. · Class II · drug

Product

Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond, WA USA 98052, NDC: 35192-044-01, UPC 7 07060 9592 1

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-0190-2026