ByHeart recalls infant formula due to potential botulism risk

Edited by: Top Class Actions | November 17, 2025

Category: Legal News

recalled formula — (Photo Credit: U.S. Food & Drug Administration)

ByHeart recall overview:

Who: ByHeart Inc. is recalling two batches of its Whole Nutrition Infant Formula.
Why: The recall is due to potential contamination with Clostridium botulinum, which can cause infant botulism.
Where: The recall is effective in the United States.

ByHeart has initiated a voluntary recall of two batches of its Whole Nutrition Infant Formula following a notification from the U.S. Food and Drug Administration (FDA) regarding an ongoing investigation into infant botulism cases.

The company is taking this action as a precautionary measure to ensure the safety of infants, despite no direct link being established between the formula and the reported cases.

The ByHeart recall, announced on Nov. 8, affects two specific batches of the formula, identified by batch codes 251261P2 and 251131P2, both with a use-by date of Dec. 1, 2026. The UPC for the affected product is 5004496800.

ByHeart emphasizes that no product has tested positive for Clostridium botulinum, and the recall is purely precautionary. “The safety and well-being of every infant who uses our formula is our absolute highest priority,” stated Mia Funt, co-founder and president of ByHeart.

Infant botulism is a rare but serious illness caused by the ingestion of Clostridium botulinum spores, which can produce toxins in the intestines of infants. Symptoms include constipation, poor feeding and respiratory difficulties.

The FDA’s investigation has reported 83 cases of infant botulism nationwide since August 2025, with 13 infants having used ByHeart formula at some point. However, no direct link between the formula and the illness has been confirmed.

ByHeart takes proactive steps to ensure infant safety

ByHeart is committed to maintaining the highest safety standards and has decided to recall the formula batches to eliminate any potential risk. The company has assured consumers that it adheres to stringent global and U.S. safety recommendations, and no contamination has been detected in their products.

“This voluntary recall is out of an abundance of caution and comes from our ongoing commitment to transparency and safety for babies and their parents,” said Funt.

Consumers who have purchased the affected batches are advised to discontinue use immediately and dispose of the product.

ByHeart is offering to replace any discarded formula from the recalled batches at no cost. For further assistance, consumers can contact ByHeart’s customer service at [email protected] or call 1 (833) 429-4327, available 24/7. Additional information can also be found on the ByHeart website.

ByHeart states that no direct link between the formula and the reported illness has been confirmed. The company is not currently facing legal action over the recall, but Top Class Actions monitors recalls closely as they sometimes lead to class action lawsuits.

Related: NEC lawsuits continue against makers of Similac and Enfamil

In related news, more than 750 NEC baby formula lawsuits have been filed against the makers of Enfamil and Similac, claiming the companies knew their products posed serious risks to premature infants but failed to warn parents and healthcare providers.

If your baby was born prematurely (before 37 weeks) and was diagnosed with necrotizing enterocolitis after using Similac or Enfamil, you may be eligible to file a baby formula lawsuit and join the ongoing multidistrict litigation. Get a free case review.

Are you affected by the ByHeart recall? Let us know in the comments.