Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Ongoing Initiated Oct 10, 2025 (12 months ago)

Gabriel Mineral Sunscreen SPF 50

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations

Cause type: cGMP deviation

Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.

What was recalled

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 NDC 35192-0044-01

Compare with the code on your package — it is the most precise check available.

Drug: Zinc

Recalling firm
CA BOTANA International, Inc.
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0190-2026 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.

Other Zinc recalls

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Class II · Moderate risk

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CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing

Ongoing Microbial contamination Church & Dwight Co., Inc. D-0790-2026
Class II · Moderate risk

Med Pride

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Ongoing cGMP deviation Dabur India Limited D-0642-2026
Class II · Moderate risk

Med Pride

CGMP Deviations; deficiencies observed during FDA inspection

Ongoing cGMP deviation Dabur India Limited D-0641-2026
Class II · Moderate risk

Med Pride

CGMP Deviations; deficiencies observed during FDA inspection

Ongoing cGMP deviation Dabur India Limited D-0637-2026

Other recalls by CA BOTANA International, Inc.

All 2025 recalls