CLASS II ONGOING Drug recall · Reported 9 Sep 2026 · FDA Enforcement Report
The One Spf 50 Invisible Sunscreen Gel, (Avobenzone recalled
Allies Group is recalling The One Spf 50 Invisible Sunscreen Gel, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, distributed nationwide in the US. The recall was initiated on 14 Aug 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0823-2026
- FDA event ID
- 99652
- Recalling firm
- Allies Group, Wilmington, DE
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Aug 2026
- FDA classified
- 31 Aug 2026
- Reported
- 9 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 14 Aug 2026 | Recall initiated by company | |
| 31 Aug 2026 | Classified by FDA | +17 days |
| 9 Sep 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the U.S.A
Questions about this recall
Why was it recalled?
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Which lots are affected?
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.
Where was it sold?
Nationwide within the U.S.A
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 99652This product is part of a recall event; the main page for the event is The One Spf 50 Invisible Sunscreen Gel, (Avobenzone recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | The One Spf 50 Invisible Sunscreen Gel, (Avobenzone recalled | Allies Group | Potency & Assay | Nationwide | |
| CLASS II | The One Spf 50 Invisible Sunscreen Gel, (Avobenzone recalled | Allies Group | Potency & Assay | Nationwide | |
| CLASS II | The One Spf 50 Invisible Sunscreen Gel, (Avobenzone recalled | Allies Group | Potency & Assay | Nationwide |
More recalls from Allies Group
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | The One Spf 50 Invisible Sunscreen Gel, (Avobenzone recalled | Allies Group | Potency & Assay | Nationwide |
| Drug | CLASS II | The One Spf 50 Invisible Sunscreen Gel, (Avobenzone recalled | Allies Group | Potency & Assay | Nationwide |
| Drug | CLASS II | The One Spf 50 Invisible Sunscreen Gel, (Avobenzone recalled | Allies Group | Potency & Assay | Nationwide |