FDA Drug Recalls

Recalls / Class II

Class IID-0523-2024

Product

ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 1 OZ (28 g), Manufactured for AGS Brands.

Affected lot / code info
Lot 04023C1, Exp 01/31/2025

Why it was recalled

Out of Specification for active ingredient

Recalling firm

Firm
ARG Laboratories, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
2639 Manana Dr, Dallas, Texas 75220-1301

Distribution

Quantity
4,013
Distribution pattern
Distributed Nationwide in the USA

Timeline

Recall initiated
2024-04-17
FDA classified
2024-05-30
Posted by FDA
2024-06-05
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0523-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls