Every Lot of ByHeart Infant Formula Remains Under Recall Over Botulism Risk
The recall applies to all batch codes and use-by dates of ByHeart Whole Nutrition Infant Formula following 48 reported illnesses.
4 reports on this incident · first at Aug 18, 2026, 12:15 a.m. ET
This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.
We last searched for new coverage of this at Aug 18, 2026, 12:37 a.m. ET — checked 9h ago.
Earlier reports
Aug 18, 2026, 12:34 a.m. ET
FDA Reports 48 Illnesses Linked to Recalled ByHeart Infant Formula
A total of 48 illness cases—comprising 28 confirmed and 20 probable cases across 17 states—have been reported in connection with ByHeart infant formula, according to the FDA as reported by Medical Daily. All 48 infants were hospitalized and treated, and no deaths were reported.
Epidemiologic and laboratory data showed that ByHeart Whole Nutrition Infant Formula was contaminated with Clostridium botulinum and made infants sick, Medical Daily reported. Infant botulism is a neurological illness beginning with constipation, poor feeding, loss of head control, and difficulty swallowing, which can advance to difficulty breathing and respiratory arrest.
Every lot of ByHeart Whole Nutrition Infant Formula remains under recall, covering all batch codes and use-by dates, including a use-by date of December 1, 2026. Recalled items include the 24-ounce can of ByHeart Whole Nutrition Infant Formula and the 0.60-ounce Anywhere Pack, which contains 14 packets per package. The product was sold online and in stores at major retailers nationwide.
Aug 18, 2026, 12:29 a.m. ET
FDA Closes ByHeart Infant Formula Recall Action
The Food and Drug Administration has closed its recall action for ByHeart Whole Nutrition Infant Formula, meaning the agency considers the recall carried out. The recall affects all batch codes and use-by dates, including products with a use-by date of December 1, 2026. The recalled products include 24-ounce cans of ByHeart Whole Nutrition Infant Formula and the 0.60-ounce Anywhere Pack containing 14 packets per package, which were sold online and in stores at major retailers nationwide.
According to reporting by Medical Daily, epidemiologic and laboratory data showed the formula was contaminated with Clostridium botulinum. Medical Daily reported 28 confirmed and 20 probable cases, totaling 48 cases across 17 states. All 48 infants were hospitalized and treated, and no deaths were reported. Medical Daily noted that infant botulism is a neurological illness beginning with constipation, poor feeding, loss of head control, and difficulty swallowing, which can advance to difficulty breathing and respiratory arrest. Every lot of ByHeart Whole Nutrition Infant Formula remains under recall.
Aug 18, 2026, 12:15 a.m. ETFirst report
ByHeart Infant Formula Recall Remains Active Over Botulism Risk
Every lot of ByHeart Whole Nutrition Infant Formula remains under recall in a developing situation, according to Medical Daily. FDA data reported by Medical Daily indicated that epidemiologic and laboratory testing showed the formula was contaminated with Clostridium botulinum and made infants sick.
Medical Daily reported 28 confirmed and 20 probable cases, totaling 48 across 17 states. All 48 infants were hospitalized and treated, and no deaths were reported. Infant botulism is a neurological illness beginning with constipation, poor feeding, loss of head control, and difficulty swallowing, which can advance to difficulty breathing and respiratory arrest.
The recall covers all batch codes and use-by dates, including a use-by date of December 1, 2026. Affected products include the 24-ounce can of ByHeart Whole Nutrition Infant Formula and the 0.60-ounce Anywhere Pack, which contains 14 packets per package. ByHeart distributed the product online and in stores at major retailers nationwide.
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- Version 118 Aug 2026, 04:54current
First published.
- Version 118 Aug 2026, 04:15current
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- Version 118 Aug 2026, 04:34current
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- Version 118 Aug 2026, 04:29current
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