California preliminary tests suggest that there is Clostridium botulinum in ByHeart infant formula, according to the California Department of Public Health (CDPH). Thirteen babies are sick with botulism poisoning after consuming that formula. The California notice now states that those illnesses are linked to ByHeart Whole Nutrition Infant Formula.
ByHeart recalled two lots of that product on November 8, 2025. The product is packaged in a 24 ounce can. The lot numbers and use by dates for the recalled product are Lot: 206VABP/251261P2 (“Use by 01 Dec 2026”) and Lot: 206VABP/251131P2 (“Use by 01 Dec 2026”). This product was sold through the company’s website and through retail stores nationwide, including Amazon, Kroger, Walmart, Whole Foods, Target, Sams Club, and others.
The product that was tested was fed to an infant with infant botulism. Eight of the 13 cases have been confirmed as toxin type A botulism, and tests are pending in the other cases.
The case count by state is: Arizona (1), California (2), Illinois (2), Minnesota (1), New Jersey (1), Oregon (1), Pennsylvania (1), Rhode Island (1), Texas (2), and Washington (1). Illness onset dates range from mid-August to November 2025. All 13 infants were treated with BabyBIG®. The infants range in age from 15 to 157 days old.
The antitoxin BabyBIG® is the only FDA-approved treatment for infant botulism. CDPH led the development of this compound in the 1990s. BabyBIG® reduces the length of hospital stays and treatment costs for infants with botulism.
Dr. Erica Pan, CDPH Director and State Public Health Officer said in a statement, “Infant botulism is a very rare disease that occurs when babies inhale or swallow spores of the toxin-producing bacteria that cause infant botulism, which leads to progressive muscle weakness including trouble breathing if not treated in time. We have tested a sample of the specific powdered infant formula linked with these cases and preliminary tests are positive. We are urging parents to stop using ByHeart formula immediately.”
If you bought this formula, stop using it immediately. You can throw it away in a secure trash can or return it to the place of purchase for a refund. Even though preliminary testing suggests there is Clostridium botulinum in ByHeart infant formula, don’t take chances.
If your baby was fed the ByHeart formula with those lot numbers and use by dates, watch carefully for any signs of infant botulism. They often begin with constipation, difficulty feeding, poor head control, and altered and weak cry, diminished facial expression, and other signs of muscle weakness. This is a medical emergency and the infant must see a doctor immediately.
If you have been sickened with a food poisoning infection, please contact our experienced attorneys for help with a possible lawsuit at 1-888-377-8900 or text us at 612-261-0856. Our firm represents clients in lawsuits against grocery stores, restaurants, and food processors.
