← FDA ENFORCEMENT
D-0195-2026Class II

CA BOTANA International, Inc.

Recalling firm
CA BOTANA International, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-12-03
Distribution
CA, CO, FL, PR, WA
Firm state
CA
Product quantity
4890 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

CGMP Deviations

Product description

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

Code / lot info

Lot D54447, exp 11/30/2027

Other recalls SPEQ maps to Risk Management & CAPA
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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.