Gabriel Mineral Sunscreen SPF 50 recall
FDA recall D-0190-2026 · initiated Oct 10, 2025
CA BOTANA International, Inc. recalled Gabriel Mineral Sunscreen SPF 50 in Oct 2025 — an FDA Class II recall (D-0190-2026) because CGMP Deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1617 tubes
Details
- 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
- Recalling company
- CA BOTANA International, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- CA, CO, FL, PR, WA
- Initiated
- Oct 10, 2025
- FDA report date
- Dec 3, 2025
Frequently asked
- Was Gabriel Mineral Sunscreen SPF 50 recalled?
- CA BOTANA International, Inc. recalled Gabriel Mineral Sunscreen SPF 50 in Oct 2025 — an FDA Class II recall (D-0190-2026) because CGMP Deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Gabriel Mineral Sunscreen SPF 50 recalled?
- Per the FDA enforcement record, the reason for recall D-0190-2026 was: CGMP Deviations
- Is a recalled Gabriel Mineral Sunscreen SPF 50 dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Gabriel Mineral Sunscreen SPF 50 are affected?
- Distributed: CA, CO, FL, PR, WA. The recall covers these lots — Lot D53371, exp 10/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0190-2026.