FDA Drugs recall ·
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%… recall
- Recall number
- D-0825-2026
- Date
- (initiated August 14, 2026)
- Company / brand
- Allies Group Inc.
1209 N Orange St, Wilmington, DE, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 23,941, 20mL-Tube
- Hazard tags
- Potency
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml - 0.7 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 074733
Why was it recalled?
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lots: H22V02A, Exp. 8/30/2026; C13W01B, Exp. 3/27/2027; C24W01, Exp. 4/28/2027; G23W02, Exp. 7/25/2027; G23W01B, Exp. 7/24/2027; K10W02, Exp. 10/21/2028.
Distribution
Nationwide within the U.S.A
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0825-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.