1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams…

Date

Dec. 17, 2025

Risk class

Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)

Status

Ongoing

Filed by

ByHeart, INC.

Product

1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams; Cans sold in 1 pack, 2 packs, 4 packs, or 6 packs 2. ByHeart Whole Nutrition Infant Formula Anywhere Packs Single Serve Packet 17 grams in packages containing 14 Single Serve Packets

Reason

Contaminated with Clostridium botulinum

Distribution pattern

nationwide

Quantity

3,482,131 Cans and 3,531,901 Single Serve Packets.

Codes and lots

All batches and codes within expiry Finished Product Quantity 08NOV2023 to 08NOV2025 UPC Codes: Single Can: 8 50044 96800 8; Sams Club 2PK: 00850044968893; Amazon 2PK: 00850044968053; Anywhere pack: 8 50044 96802 2; 1-Count Sample Unit Anywhere Pack: 850044968015

Recall started

Nov. 8, 2025

Recall number

H-0249-2026

What should I do? A baby or kids' product was recalled: what to do

Source: FDA · Food enforcement report, recall number H-0249-2026. The agency record governs; check it and the company before acting.