A baby formula company has expanded its recall to include every product it makes after finding dangerous bacteria in unopened containers.

What’s Happening: ByHeart now says all of its formula across all product lots may be contaminated with Clostridium botulinum Type A — the bacteria that causes infant botulism. The company found the bacteria in five of 36 unopened samples it tested from three different lots.

What’s Important: This is a major change from two weeks ago. On November 11, ByHeart recalled specific batches and said no unopened cans tested positive for bacteria. Now the company admits it cannot rule out contamination in any of its products.

Between the Lines: The expanded recall covers far more than the initial products pulled on November 11. Every can and Anywhere Pack of ByHeart formula is now included. The company is offering full refunds for all purchases made since August 1 — when the first baby in the outbreak got sick.

The Impact: At least 15 babies in 12 states have been hospitalized after drinking ByHeart formula since August. Of 84 infant botulism cases reported since August, 36 babies drank infant formula. More than a third of those babies drank ByHeart — even though the brand makes up only 1% of the baby formula market.

What Parents Need to Watch For: Symptoms of infant botulism can appear 3 to 30 days after a baby consumes the bacteria. Warning signs include constipation followed by feeding problems, weak or altered cry, droopy eyelids, diminished facial expressions, loss of head control and lethargy. Parents should contact a doctor immediately if their child shows any symptoms.

The Refund Process: Parents can call 866-201-9069 to request refunds for any ByHeart purchases made on or after August 1, 2025. Refunds should arrive within 5 to 7 business days.

The Sources: ByHeart letter to customers.


B.T. Clark
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B.T. Clark is an award-winning journalist and the Publisher of The Georgia Sun. He has 25 years of experience in journalism and served as Managing Editor of Neighbor Newspapers in metro Atlanta for 15 years and Digital Director at Times-Journal Inc. for 8 years. His work has appeared in several newspapers throughout the state including Neighbor Newspapers, The Cherokee Tribune and The Marietta Daily Journal. He is a Georgia native and a fifth-generation Georgian.