FDA recall D-0183-2026

CA BOTANA International, Inc. · Class II · drug

Product

Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC: 35192-042-02

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-0183-2026