Infant Botulism Cases Tied to ByHeart Formula Rise to 37 in 17 States

The Food and Drug Administration said Wednesday that 37 babies have been sickened in an infant botulism outbreak tied to ByHeart infant formula, up from 31 a week earlier, NBC News (via the Associated Press) and CBS News reported.

All the infants, aged about 2 weeks to about 9 months, were hospitalized after consuming ByHeart powdered formula, and no deaths have been reported, NBC News reported. Illnesses began between Aug. 9 and Nov. 19, the FDA said, and cases have been reported in 17 states. The outbreak was announced on Nov. 8.

ByHeart recalled all of its U.S. products on Nov. 11, according to NBC News. The company, which has about 1 percent of the U.S. infant formula market, had been selling about 200,000 cans a month. CBS News reported on Nov. 19 that cases had doubled since the recall was widened and that the FDA had received multiple reports that the formula was still on store shelves in several states, and that recalled products were sold online and shipped outside the U.S.

The FDA said ByHeart is “disproportionately represented among sick infants in this outbreak,” and its inspectors have visited the company’s plants in Allerton, Iowa, and Portland, Oregon, NBC News reported. California officials confirmed that a sample from an open can fed to a sick baby contained the type of bacteria that can cause the illness, and the company has said lab tests confirmed some samples were contaminated, NBC News reported.

Families of babies treated for botulism have sued ByHeart in federal courts, alleging the formula was defective and the company negligent, NBC News and CBS News reported. ByHeart has said it will “address any legal claims in due course,” CBS News noted.

Medical experts say symptoms can take up to 30 days to develop, NBC News reported. The CDC lists poor feeding, loss of head control, drooping eyelids, a flat facial expression and trouble swallowing or breathing among the signs, per CBS News.

Infant botulism typically affects fewer than 200 babies a year in the United States. The CDC had counted 133 cases as of Sept. 20 this year, compared with 145 in all of last year, NBC News reported.