Drug & medication recalls Moderate risk

CLEARSTEM YOU ARE SUNSHINE SPF 50 recalled over manufacturing violations

Recall date
October 10, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
CA BOTANA International, Inc. recalls CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstem…
Recall number
D-0195-2026
FDA classification
Class II
Brand / firm
CA BOTANA International, Inc.
Sold / distributed
CA, CO, FL, PR, WA

Why it was recalled

CGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17

Get recall alerts

Free email alert whenever CA BOTANA International, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: CA BOTANA International, Inc.