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FDA investigates 13 infant botulism cases linked to two lots of ByHeart infant formula, prompting a recall.
The FDA is investigating 13 infant botulism cases across 10 states linked to two lots of Whole Nutrition Infant Formula by ByHeart Inc., prompting a recall of lots 206VABP/251261P2 and 206VABP/251131P2.
All affected infants were hospitalized but no deaths occurred.
The formula, available online and in stores, made up about 1% of national sales.
Parents are advised to check lot numbers, discard or return the product, clean contaminated surfaces, and seek medical care if infants show symptoms like poor feeding, weakness, or breathing difficulties.
The FDA is probing contamination sources and whether other products are affected.
La FDA investiga 13 casos de botulismo infantil vinculados a dos lotes de fórmula infantil ByHeart, lo que provocó un retiro del mercado.