FDA Says Recalled Infant Formula Is Still on Store Shelves as Botulism Cases Continue to Increase

The U.S. Food and Drug Administration (FDA) is warning consumers that recalled ByHeart Whole Nutrition infant formula is still being found on store shelves in several states, including multiple Walmart, Target and Kroger locations, as cases of infant botulism linked to the product continue to grow.

All ByHeart Whole Nutrition Infant Formula products, including unexpired lots of formula cans and single-serve “anywhere pack” sticks, were recalled after epidemiologic and laboratory data determined the product could be contaminated with Clostridium botulinum. 

However, FDA said it has received reports that recalled formula is still being found on store shelves in multiple states. In addition to Walmart, Target and Kroger, the agency said one or more Sprouts Organic Market, Safeway, Jewel-Osco, Shaw’s and Star Market locations have also been reported for selling recalled product.

FDA said it is working with state partners and retailers to ensure an effective recall and immediate removal of all ByHeart infant formula products from store shelves across the country.

As of Nov. 19, 31 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 15 states. Laboratory confirmation for some cases is ongoing.

For 27 cases with illness onset information available, illnesses started on dates ranging from Aug. 9 to Nov. 13. All 31 infants were hospitalized. No deaths have been reported. For 23 infants with age and 24 with sex information available, they range in age from 16 to 200 days, and 11 (46%) are female. 

Cases have been confirmed in Arizona, California, Idaho, Illinois, Kentucky, Maine, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington. 

The FDA is investigating the outbreak along with the Centers for Disease Control and Prevention (CDC), the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP) and other state and local partners.

As part of the investigation, ByHeart tested unopened infant formula products retained at its facility. According to ByHeart, third-party laboratory analysis of some samples identified Clostridium botulinum, which produces the toxin that is making infants sick in this outbreak. ByHeart stated that it will continue to investigate these findings and perform ongoing testing to identify the source of contamination, said FDA.

Recalled product was also sold through online marketplaces and shipped to customers outside of the United States. Consumers worldwide should not use any ByHeart brand infant formula, said FDA. More information on international distribution, including a list of countries where consumers received recalled product, is available here.