← FDA ENFORCEMENT
D-0187-2026Class 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
874 tubes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

CGMP Deviations

Product description

Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-011-02

Code / lot info

Lot D53950, exp 5/31/2027

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.