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THE ONE SPF 50 INVISIBLE SUNSCREEN GEL recall

FDA recall D-0823-2026 · initiated Aug 14, 2026

By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated Sep 9, 2026How we research

Allies Group Inc. recalled THE ONE SPF 50 INVISIBLE SUNSCREEN GEL in Aug 2026 — an FDA Class II recall (D-0823-2026) because Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

Wrong strength, or it did not keep

The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.

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.

Lots: H22V01 Exp. 8/29/2026, H22V02 Exp. 8/30/2026, K22V02A Exp. 10/29/2026, M10V01 Exp. 01/21/2027, G23W02B Exp. 7/25/2027, G23W03 Exp. 8/4/2027, G23W03D Exp. 8/4/2027, K10W01A Exp. 10/17/2028, K10W01C Exp. 10/17/2028, M11W02 12/17/2028, F09X02 Exp. 6/17/2029.

Quantity recalled: 29,014 50mL Tubes

Details

Product
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML - 1.7 fl. oz Tube, Made in U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 073224
Recalling company
Allies Group Inc.
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Nationwide within the U.S.A
Initiated
Aug 14, 2026
FDA report date
Sep 9, 2026
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Frequently asked

Was THE ONE SPF 50 INVISIBLE SUNSCREEN GEL recalled?
Allies Group Inc. recalled THE ONE SPF 50 INVISIBLE SUNSCREEN GEL in Aug 2026 — an FDA Class II recall (D-0823-2026) because Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label. May cause temporary or medically reversible harm; low probability of serious harm.
Why was THE ONE SPF 50 INVISIBLE SUNSCREEN GEL recalled?
Per the FDA enforcement record, the reason for recall D-0823-2026 was: Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Is a recalled THE ONE SPF 50 INVISIBLE SUNSCREEN GEL 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 THE ONE SPF 50 INVISIBLE SUNSCREEN GEL are affected?
Distributed: Nationwide within the U.S.A. The recall covers these lots — Lots: H22V01 Exp. 8/29/2026, H22V02 Exp. 8/30/2026, K22V02A Exp. 10/29/2026, M10V01 Exp. 01/21/2027, G23W02B Exp. 7/25/2027, G23W03 Exp. 8/4/2027, G23W03D Exp. 8/4/2027, K10W01A Exp. 10/17/2028, K10W01C Exp. 10/17/2028, M11W02 12/17/2028, F09X02 Exp. 6/17/2029.. 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-0823-2026.

Source: openFDA Drug Enforcement record D-0823-2026 ↗

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