Drug & medication recalls Moderate risk

Sea Enzyme Ultra Umbrella Sunscreen SPF 30 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 Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by…
Recall number
D-0187-2026
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

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

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