ByHeart Updates Information Regarding Voluntary Recall of all Batches of ByHeart Whole Nutrition Infant Formula Cans and Packs Because of Possible Health Risk

Raleigh, N.C., Nov. 19, 2025 — ByHeart has announced a voluntary recall of all ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ products after testing identified Clostridium botulinum in some samples, linked to a multistate outbreak of infant botulism. The bacterium can cause life‑threatening illness in infants; consumers are urged to stop using the product immediately and not to feed it to infants even if it looks or smells normal. Parents should seek immediate medical attention if an infant shows symptoms such as poor feeding, weak cry, constipation, low muscle tone, difficulty breathing or swallowing.

The recall covers ByHeart Whole Nutrition Infant Formula, 24 oz cans (UPC: 5004496800) and ByHeart Whole Nutrition Infant Formula Anywhere Pack™, 0.60 oz packets, 14 per package (UPC: 5004496802); it is being applied to all lot code(s) and use‑by dates. The products have been sold online and at select U.S. retailers and have been sold since Sept. 15, 2025; if you purchased these items in Canada, stop using them immediately and follow local guidance. Consumers should check the bottom of their containers for identifying information and preserve the package for possible testing by public health authorities.

Consumers should discontinue use, label containers DO NOT USE, and either return the product to the place of purchase or follow disposal instructions from local health authorities; if a refund or replacement is desired, contact ByHeart at [email protected] or call 1‑833‑429‑4327, available 24/7. To report illness or adverse events, follow FDA reporting guidance (electronic or paper MedWatch) or state reporting systems; keep the container if your health department requests it for testing and dispose only if advised and no symptoms develop within 30 days. For additional information and updates, visit byheart.com or consult FDA and state public health advisories.