When is a ByHeart Infant Formula Botulism Recall not a Recall? When it is not!

Retailers around the world are urged to pay attention. Selling recalled product – especially infant formula with botulism – is a bad idea for your customers and a bad idea for your liability exposure – including punitive damages.

As of last week the FDA continues to receive reports that recalled formula is still being found on store shelves at Walmart, Target, Kroger, Acme, and Shaw’s, despite the ongoing recall of all ByHeart infant formula products. FDA continues to work with state partners and retailers to ensure an effective recall and immediate removal of these products from store shelves across the country. All ByHeart infant formula products have been recalled, and these products should not be available for sale in stores or online. This includes all formula cans and single-serve “anywhere pack” sticks.

In addition, the ByHeart infant formula recall impacts markets outside the United States. Customer information provided by Amazon shows that a limited quantity of recalled ByHeart infant formula was distributed to Argentina, Brazil, Brunei, Canada, Chile, China, Colombia, Ecuador, Egypt, Hong Kong, Israel, Jamaica, Japan, Republic of Korea, Peru, Philippines, Romania, Singapore, South Africa, Thailand, and the British Virgin Islands.

The FDA urges consumers worldwide should not use any ByHeart brand infant formula as all ByHeart products are included in this recall.

The CDC reported as of December 3, 2025, a total of 39 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 18 states: Arizona 3, California 5, Idaho 1, Illinois 2, Kentucky 1, Massachusetts 2, Maine 1, Michigan 1, Minnesota 2, North Carolina 2, New Jersey 1, Oregon 4, Pennsylvania 1, Rhode Island 1, Texas 8, Virginia 1, Washington 2 and Wisconsin 1.

Laboratory confirmation for some cases is ongoing. Illnesses started on dates ranging from August 9 to November 19, 2025. All 39 infants were hospitalized. No deaths have been reported to date. For 38 infants with age and 39 with sex information available, they range in age from 16 to 264 days and 15 (38%) are female.

The FDA has reported that due to the large number of samples, only positive results are being reported here. The detection of Clostridium botulinum in infant formula is complex, and a negative test result does not rule out the presence of the bacteria in the product.

Parents and caregivers should not use any ByHeart infant formula, regardless of test results.

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.