THE ONE SPF 50 INVISIBLE SUNSCREEN GEL — Class II drug recall D-0824-2026
Ongoing recall by Allies Group Inc., reported 2026-09-09, distributed nationwide. Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection
| Recall number | D-0824-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Allies Group Inc., Wilmington, DE, United States |
| Recall initiated | 2026-08-14 |
| Classified | 2026-08-31 |
| Reported by FDA | 2026-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 27,492 |
| Reason classes | labeling, potency |
| Lot numbers | C13W01A, G23W01A, M04W01 |
| Expiration dates | 2027-03-27, 2027-07-24, 2028-12-10 |
Product
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914.UPC 8 885014 073293
Reason for recall
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0824-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.