ByHeart Infant Formula Recall Issued Due to Botulism Risks

Manufacturer is urging consumers to immediately stop feeding the recalled infant formula batches to children.

Federal health officials say 13 infants across 10 states have developed botulism infections that are believed to be linked to contaminated ByHeart brand infant formula.

The U.S. Food and Drug Administration (FDA) announced the ByHeart Whole Nutrition Infant Formula recall on November 8, after detecting an unusual increase in infant botulism cases among babies who consumed the product. The agency is continuing its investigation while warning parents and caregivers to immediately stop using cans from the affected lots.

Infant Botulism Risks

Although infant botulism is rare, it can lead to serious and potentially life-threatening side effects.

The illness occurs when Clostridium botulinum spores, which occur naturally in environmental sources like soil, some vegetables and dust, are ingested and colonize the intestinal tract. The spores produce botulinum neurotoxins in the young guts of infants.

Botulinum is uncommon in dairy products or infant formula. However, federal regulators are warning parents that infants who experience botulism may present symptoms such as:

• Difficulty sucking and swallowing
• Weak or altered cry
• Respiratory difficulty and arrest
• Constipation
• Poor feeding
• Droopy eyelids
• Sluggish pupils
• Low muscle tone and weakness

The FDA has identified approximately 83 cases of infant botulism nationwide since August 2025. Among those, 13 infants had consumed ByHeart Whole Nutrition Infant Formula before becoming sick. No deaths have been reported in connection with the outbreak.

The reported illnesses occurred among infants in:

Although investigators have not yet confirmed a direct link between the formula and the infections, federal regulators notified ByHeart of the ongoing investigation, prompting the company to initiate a voluntary recall as a precautionary measure.

The recall applies to two batches of ByHeart Whole Nutrition Infant Formula: Batch Code 251261P2 and Batch Code 251131P2, both with a Use By date of December 1, 2026, and UPC 5004496800. The batch code and use-by date are printed on the bottom of the can.

The FDA continues to investigate the source of contamination and has warned consumers to immediately stop using formula from the affected lots. ByHeart has also urged parents and caregivers to discard any recalled cans, stating that replacement products will be provided at no cost.

Infants showing symptoms of botulism should receive immediate medical care. Any illnesses or side effects linked to the recalled formula should be reported to the FDA’s MedWatch Adverse Event reporting program.

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