Unusual recall reason due to possible infant botulism

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Nov 24, 2025 - Foods

Unusual recall reason due to possible infant botulism

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As part of a voluntary recall through the US Food and Drug Administration (FDA), a warning notice for two batches of infant formula from a company was also released in Germany via the portal Lebensmittelwarnung.de, published .

The FDA had previously announced an investigation into a possible outbreak of infant botulism.

Botulism in infants is a rare but potentially life-threatening disease. Clostridium botulinum spores can be ingested through contaminated infant formula and settle in the intestines, where the dangerous botulinum neurotoxins – the most potent known biological toxins – can be produced. In the EU, cases of botulism occur only sporadically, mostly in connection with home-smoked foods or improperly prepared canned foods in private households. A previous unusual case involved the public recall of coconut water due to insufficient pasteurization (🔗 https://www.inside-getraenke.de/nachrichten/detail/news/rueckruf-king-coconut-water).

Typical clinical signs of infant botulism include poor feeding, ptosis, decreased muscle tone, sucking and swallowing difficulties, reduced vocalization, breathing problems up to respiratory arrest, and constipation. Since Clostridium botulinum is an obligate anaerobe, cultural detection requires special cultivation conditions.

Further background information is provided by the following sources, among others:
PDF: Rare, but preventable – Questions and answers on botulism (local file, original link: file:///C:/Users/gerob/Downloads/Selten__aber_vermeidbar__Fragen_und_Antworten_zum_Botulismus.pdf)
Federal Institute for Risk Assessment (BfR): Consumer advice (🔗 https://www.bfr.bund.de/cm/350/hinweise_fuer_verbraucher_zum_botulismus_durch_lebensmittel.pdf)

For further questions, the company's customer advisors are available.

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