ITHACA, NY (607NewsNow) – A recall of baby formula is expanding.

Last month, federal officials warned consumers to stop using all recently manufactured ByHeart formula products because of an infant botulism outbreak.

At the time, there were 15 suspected or confirmed cases in 12 states. According to the FDA, that number has swelled to 51 cases in 19 states. The initial investigation reviewed products from August 1, 2025, and on. After the CDC broadened the case definition, officials uncovered an additional 10 cases between December 2023 and July 2025.

The FDA says it “cannot rule out the possibility” that contamination may have affected all ByHeart products since their release in March 2022; however, to date, no cases have been identified prior to December 2023.

All 51 infants who became ill were hospitalized, but no deaths have been reported.

Tompkins County Medical Director Dr. William Klepack joined Ithaca’s Morning News on November 12 to discuss infant botulism. Click here to listen to the full interview.