(Commonwealth Healthcare Corp.) — Please be advised that the CHCC Environmental Health Disease and Prevention Program, with guidance from the U.S. Food and Drug Administration and the assistance of Women, Infant & Children Program, have inspected stores in the CNMI for the ByHeart Whole Nutrition Infant Formula, which have been recalled in an ongoing FDA Investigation.
The product in question has the potential to be contaminated with Clostridium botulinum (botulism).
The CHCC-EHDP has completed an assessment in Saipan, Tinian and Rota and did not find any of the affected products in stock or on store shelves.
However, consumers who purchase products online or outside of the CNMI should be aware of this recall.
As of Dec. 10, 2025, the FDA’s investigation was ongoing. However, reports of cases linked to this outbreak have slowed. There have been no reported cases here in the CNMI.
What is Clostridium Botulism and why should you be concerned?
C. botulinum is responsible for a disease called botulism. Botulism is a life-threatening disease caused by the ingestion of a potent neurotoxin produced during growth of the C. botulinum bacteria. This neurotoxin is among the most toxic substances known; even microscopic amounts can cause illness or death.
Symptoms of Infant botulism:
– initially develop constipation
– poor feeding
– loss of head control
– difficulty swallowing (progress to difficulty breathing and respiratory arrest)
What should parents do?
CHCC is urging parents and caregivers not to feed their children ByHeart Infant Formula.
CHCC advises consumers who have purchased ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack should immediately discontinue use and dispose of the product. Note that the EHDP did not find this affected product in stores in Saipan, Tinian or Rota.
The voluntary recall applies to all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Packs.
“We thank all our wholesale and food distributors for their continued partnership and cooperation in keeping our community healthy and safe.”
For more information, contact the EHDP office at (670) 236-2022/27/28, or email the administrator of EHDP, John Tagabuel, at john.tagabuel@chcc.health or visit https://fda.gov/.
For more information about its programs, follow CHCC on Facebook, Instagram, and X (Twitter) at @cnmichcc, check out www.chcc.gov.mp or call (670) 234-8950.
