This week, the infant formula brand ByHeart has issued a voluntary recall of all batches of ByHeart Whole Nutrition Infant Formula cans and single-serve Anywhere PackTM sticks sold nationwide, including in-office samples. This recall is in response to an infant botulism outbreak, in close collaboration with the U.S. Food and Drug Administration (FDA). ByHeart is posting continuous updates for consumers and clinicians on its website.
Infant botulism occurs when a baby swallows spores of Clostridium botulinum that colonize the baby’s large intestine and produce botulinum toxin. Infant botulism often starts with constipation followed by difficulty feeding (sucking and swallowing), a weak and altered cry, diminished facial expression, droopy eyelids, loss of head control, and lethargy. It requires immediate medical attention and is life-threatening.
Consumers are advised to NOT use any ByHeart Whole Nutrition infant formula.
If your infant develops symptoms:
- Immediately contact your healthcare provider
- Report an illness or adverse event by calling the FDA Consumer Complaint Coordinator for your state (found on the FDA’s website) or filling out the FDA Form 3500 online.
If you are a clinician and suspect an infant patient has botulism, call 510-231-7600 for case consultation (available 24/7).