(NewsNation) — A manufacturer of powdered infant formula is recalling some product as federal authorities investigate an outbreak of more than a dozen infant botulism cases in 10 states, the FDA said Saturday.
Officials say there may be a link between 13 cases of infant botulism to ByHeart powdered infant formula; testing of leftover product continues.
No deaths have been reported in the states where the cases have occurred: Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.
The FDA said in an online bulletin that ByHeart, Inc. has agreed to voluntarily recall two lots of Whole Nutrition Infant Formula that reportedly were consumed by the infants who became ill. On its website, the company said its recall applies to two batches produced earlier this year:
- Batch Code: 251261P2, Use by: 01 Dec 2026
- Batch Code: 251131P2, Use by: 01 Dec 2026
ByHeart urges anyone with these products to discard them, and the company will replace the cans with new product. The company can be reached at hello@byheart.com.
“No other batches have been impacted by this investigation,” the manufacturer said.
Infants with botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing, but these symptoms can progress to difficulty breathing and respiratory arrest, the FDA said.
Symptoms can take as long as several weeks to develop following formula ingestion.