In Response to a Broader FDA Investigation, ByHeart Initiates a Voluntary Recall of Two Batches of Infant Formula

Raleigh, N.C., Jan. 14, 2026 — ByHeart, a baby nutrition company, has voluntarily recalled two batches of ByHeart Whole Nutrition Infant Formula after notification from the U.S. Food and Drug Administration of an ongoing investigation into a nationwide outbreak of infant botulism. The company says the recall is an abundance-of-caution measure; infant botulism is a rare but potentially fatal illness caused by Clostridium botulinum spores producing neurotoxin in an infant’s immature gut. Consumers who possess the affected cans should stop using them immediately and discard or isolate them to prevent accidental use.

The voluntary recall applies to the following product identification: ByHeart Whole Nutrition Infant Formula, lot code(s) 251261P2 and 251131P2 (use by: Dec. 1, 2026), UPC 5004496800; the batch code and use-by date appear on the bottom of the can. These lots have been sold online and at select U.S. retailers and have been sold since Sept. 15, 2025. No other ByHeart lots are included in this recall, and ByHeart and regulatory testing to date have not detected C. botulinum spores or toxin in its products.

Consumers should immediately stop using recalled cans and either dispose of them or request a replacement or refund through ByHeart; parents who have already discarded cans may still obtain replacements at no cost. If an infant shows symptoms consistent with botulism—such as constipation, poor feeding, weak cry, drooping eyelids, or respiratory difficulty—seek medical care immediately. To report an illness or adverse event, contact FDA Consumer Complaint Coordinators or submit a MedWatch report; consumers with questions or to request return, refund, or replacement should email [email protected] or call 1-833-429-4327 (24/7).