ByHeart, INC.

FDA Regulatory Profile

ByHeart, INC. appears in FDA public data with 2 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (H-0249-2026, Class I) was initiated on November 8, 2025.

Summary

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

Recent Recalls

NumberClassProductDate
H-0249-2026Class I1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams; Cans sold in 1 pack, 2 packs, 4 packNovember 8, 2025
F-0291-2023Class IBy Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680 gDecember 11, 2022