Recalls / Class II

Class IID-0190-2026

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

Affected lot / code info

Lot D53371, exp 10/31/2026

Why it was recalled

CGMP Deviations

Recalling firm

Firm

CA BOTANA International, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

9505 Chesapeake Dr, N/A, San Diego, California 92123-1304

Distribution

Quantity

1617 tubes

Distribution pattern

CA, CO, FL, PR, WA

Timeline

Recall initiated

2025-10-10

FDA classified

2025-11-26

Posted by FDA

2025-12-03

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0190-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.