In a recent development, a powdered infant formula manufacturer has initiated a product recall as federal authorities delve into a botulism outbreak affecting infants across 10 states. The FDA disclosed this situation on Saturday, noting that the outbreak has involved more than a dozen cases.

Authorities are currently examining a potential connection between 13 infant botulism cases and ByHeart’s powdered infant formula, with ongoing tests on remaining product samples.

Fortunately, no fatalities have been reported in the affected states, which include Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.

The FDA’s online announcement confirmed that ByHeart, Inc. has opted to recall two batches of their Whole Nutrition Infant Formula, which were reportedly consumed by the affected infants. Further details on this recall can be found on their website.

• Batch Code: 251261P2, Use by: 01 Dec 2026
• Batch Code: 251131P2, Use by: 01 Dec 2026

ByHeart advises consumers to dispose of these specific products and offers to replace them with fresh ones. For more assistance, the company is reachable 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.