Cans of baby formula sold across 10 states are being recalled because of a life-threatening bacterial risk.

ByHeart Inc., a New York-based infant food company, is pulling two batches of baby formula from shelves amid a federal investigation of dozens of botulism cases across the country.

ByHeart Inc. products included in the recall were sold in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.

The company issued a voluntary recall on Nov. 8, 2025, after the U.S. Food and Drug Administration informed the manufacturer of a nationwide investigation into 83 reported infant botulism cases since August.

Among those cases, 13 infants had consumed ByHeart formula at some point, though health officials have found no direct connection between the illnesses and any infant formula brand.

“The safety and well-being of every infant who uses our formula is our absolute highest priority,” said Mia Funt, co-founder and president of ByHeart.

“While no testing by ByHeart or regulatory agencies has confirmed the presence of Clostridium botulinum spores or toxin in any ByHeart product, we are taking this proactive step to remove any potential risk from the market.”

Infant botulism occurs when babies ingest Clostridium botulinum spores that produce toxins in the intestinal tract.

The rare but serious illness can cause constipation, poor feeding, drooping eyelids, sluggish pupils, low muscle tone, a weak cry and respiratory difficulty.

No ByHeart products have tested positive for contaminants as of Nov. 10, according to the company.

recalled batches should stop using it

Both batches carry a use-by date of Dec. 1, 2026.

The batch code and date are listed on the bottom of the can. The UPC for the affected product is 5004496800. No other batches are included in the recall.

Parents who purchased formula from recalled batches should stop using it immediately and throw it away.

The company will replace affected cans at no charge.

Parents concerned about symptoms in their infants should contact a health care provider.

Questions about the recall can be directed to [email protected] or 1-833-429-4327.

Generative AI was used to draft this story, based on information provided by the U.S. Food and Drug Administration. It was reviewed and edited by MassLive staff.