The FDA has made additional reports on inspections of ByHeart infant formula plants available. The company’s formula has been determined to be the source of at least 37 cases of infant botulism.

The outbreak is spread across 17 states. All 37 of the infected babies have been hospitalized. Another 70 cases are under investigation.

A Clostridium botulinum spore is a tough, dormant form of the Clostridium botulinum bacterium that allows it to survive in harsh environmental conditions for long periods. These spores are widespread in soil, dust, and marine sediments and are generally harmless in their dormant state.

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While there are 37 known confirmed cases of infant botulism linked to ByHeart infant formula in the United States, it is not yet known whether there are cases in any of the 21 other countries that received the formula.

In an Oct. 25 warning letter the Food and Drug Administration outlined problems found at Granja Asomante, Road 569 Km 5.5 Interior, Orocovis 00720, Puerto Rico.

Food recalls in Europe and the United Kingdom have gone up again, according to the latest data from Sedgwick’s European Product Safety and Recall Index.

In the third quarter of 2025 (Q3) recalls in the food and drink sector went up by 6 percent.

Five potential European Union countries have had their food safety controls evaluated as part of efforts to align systems with EU requirements.