FDA recall D-0185-2026

CA BOTANA International, Inc. · Class II · drug

Product

Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-016-05

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-0185-2026