D-0825-2026 Class II Ongoing
FDA drug recall D-0825-2026 was initiated by Allies Group Inc. on August 14, 2026 and is designated Class II. Reason for recall: Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label. The recall status is ongoing. Affected quantity: 23,941, 20mL-Tube.
Recall Details
- Product Type
- Drugs
- Report Date
- September 9, 2026
- Initiation Date
- August 14, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,941, 20mL-Tube
Product Description
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
Reason for Recall
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Distribution Pattern
Nationwide within the U.S.A
Code Information
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.