FDA Drugs recall ·

Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz… recall

Recall number
D-0190-2026
Date
(initiated October 10, 2025)
Company / brand
CA BOTANA International, Inc.
9505 Chesapeake Dr, San Diego, CA, United States
Category
Drugs › Class II
Classification
Class II
Status
Ongoing
Units affected
1617 tubes
Hazard tags
Manufacturing practices (cGMP)
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond, WA USA 98052, NDC: 35192-044-01, UPC 7 07060 9592 1

Why was it recalled?

CGMP Deviations

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot D53371, exp 10/31/2026

Distribution

CA, CO, FL, PR, WA

States: California Colorado Florida Puerto Rico Washington

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0190-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.