FDA recall D-0194-2026

CA BOTANA International, Inc. · Class II · drug

Product

Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-050-17, UPC 6 7229 99913 8

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-0194-2026