Investigation Launched into Infant Botulism Cases Linked to Baby Formula Recall

Tue Nov 11 2025 09:41:50 GMT+0200 (Eastern European Standard Time)

Federal and state health officials are probing 13 infant botulism cases across 10 states linked to a recall of ByHeart Inc.'s Whole Nutrition Infant Formula. The FDA has confirmed the recall of specific lots and is investigating potential contamination sources.

Thirteen infants have been hospitalized due to botulism linked to ByHeart Inc.’s recalled Whole Nutrition Infant Formula. The FDA is currently investigating the cause of contamination as reports have emerged from ten states, although no fatalities have been reported. The public is urged to take precautions if they have the affected formula.

Federal and state health officials are investigating 13 cases of infant botulism associated with baby formula, which prompted a recall by ByHeart Inc. on Saturday. The Food and Drug Administration announced that two lots of the Whole Nutrition Infant Formula are subject to the recall due to health concerns.

All affected infants, hospitalized after consuming the contaminated formula, are linked to lot numbers: 206VABP/251261P2 and 206VABP/251131P2. Reports of these cases have come from a total of 10 states including Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.

No fatalities have been reported in conjunction with these cases, but the FDA is actively investigating the source of contamination and evaluating if it may affect other products in the market.

The formula, which represents approximately 1% of national sales, is widely available online and at major retail outlets, prompting officials to recommend that consumers check lot numbers before discarding or returning the product.

To ensure safety, the Centers for Disease Control and Prevention (CDC) advises using hot, soapy water or a dishwasher to clean items and surfaces that came into contact with the formula. Parents should seek immediate medical attention if their infants display symptoms like poor feeding, loss of head control, difficulty swallowing, or reduced facial expression after consuming the recalled product.

Infant botulism occurs when a bacterium produces dangerous toxins in the intestines of infants. Symptoms may develop over several weeks, making vigilance essential for parents. A spokesperson from ByHeart did not immediately respond to requests for further comments on the situation, which continues to unfold.