Orgain

FDA Regulatory Profile

Orgain appears in FDA public data with 2 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (F-0386-2025, Class I) was initiated on December 17, 2024.

Summary

Total Recalls
2 (2 Class I)
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
F-0386-2025Class IOrgain 30g Plant Protein, Complete Protein Powder, 6g Prebiotic +Fiber, 9g EAAS+BCAAs, 1gSugar, ChocDecember 17, 2024
F-0302-2024Class IOrganic Protein & 50 Superfoods Protein Powder with Probiotic - Chocolate flavorSeptember 28, 2023