FDA recall D-0187-2026

CA BOTANA International, Inc. · Class II · drug

Product

Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-011-02

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-0187-2026