Product recall notices happen often, and it’s normal to feel anxious or concerned, especially when the product involves your child. Let’s go over some facts and frequently asked questions:
Why were these products recalled?
ByHeart Formula (ByHeart Whole Nutrition Infant Formula®)
- In December 2022, a single sample at the formula’s packaging plant tested positive for a bacteria germ named Cronobacter sakazakii. No sold batches of formula have been found to be contaminated, and there are no reports of illness. The company voluntarily chose to recall five batches of formula to be cautious. If you would like to learn more about Cronobacter germs scroll to the bottom of this page.
Abbott formula (Similac® and Pedialyte®):
- In October 2022, some samples of ready-to-feed liquid products, including Similac and Pedialyte, were found to have the potential for compromised seal integrity (bottle caps that may not have sealed completely) in a small percentage (less than 1%) included in the recall lots, which could result in product spoilage.
- Previously, in February 2022, some samples were found to contain bacteria with the scientific names Cronobacter sakazaij and Salmonella newport. In rare cases, these bacteria could make babies sick. If you would like to learn more about these bacteria, scroll to bottom of this page.
Lyons Magnus (Kate Farms, Pediasure Harvest and others):
- In February 2022, some samples were found to contain Cronobacter sakazaki. The company has said its products might have a risk of having another bacteria, Clostridium botulinum, but this has not been found so far. If you would like to learn more about these bacteria, scroll to bottom of this page.
How do I check the label to know if my product was affected?
You can look at the manufacturers’ website to see if your product should not be used.
For ByHeart, visit byheart.com
For Abbott (including Similac and Pedialyte), visit similacrecall.com.
For Lyons Magnus (Kate Farms, Pediasure Harvest and others), visit Lyonsmagnus.com.
What should I do if my product is affected by the recall?
If you are using formula from the impacted lots referenced above, you should stop using it. It is very rare for a child to become sick after drinking these products. However, you should still monitor your child to see if any symptoms develop.
What are the symptoms I should look for?
If spoiled product is consumed, gastrointestinal issues such as vomiting and diarrhea could result. Symptoms of infections caused by bacteria from these products could include changes in appetite/ feeding, diarrhea, vomiting, changes in mood (irritated or overly sleepy compared to normal), fevers, rash, changes in muscle tone, drooping eyelids, drooling more than baseline, yellow skin and whites of the eyes, grunting breaths and abnormal movements.
What should I do if my child is exhibiting symptoms?
If your child has been fed with recalled formula and is having symptoms that are different from their baseline, please call your pediatrician or health care provider.
- Take your child to the emergency room if they are having difficulty breathing or having abnormal movements.
When can I feel safe that my child will not have negative effects after drinking the recalled formula?
Infections with these bacteria are very rare, even in children exposed to the recalled formula. The vast majority of exposed children will never become ill. It is unlikely that a child would become ill more than 2 weeks after exposure to these bacteria.
What do I do if I need a new formula?
Remember, this recall is only for specific lots of formula. You may continue to use the same brand of formula as long as it is not part of the affected lot.
If you purchased your formula from a store and not because of a specific recommendation from your baby’s health care provider, then you can purchase an alternative product. (You may even choose the same brand, as long as it’s a different “lot”).
If your child's health care provider recommended this product specifically for your child, then please reach out to them for more guidance.
If you receive your product through a pharmacy or medical supplier, you will need a new prescription from your pediatrician or health care provider.
How do I contact the company if I would like a replacement or refund or to tell them about my experience?
For a refund or replacement, reach out directly to the manufacturer:
ByHeart will be reaching out to its online customers. The company can be contacted by email at email@example.com or by calling 1-909-506-2354.
Abbott can be contacted through similacrecall.com or by calling 1-800-986-8540.
Lyons Magnus can be contacted through www.lyonsmagnus.com. Or by calling 1-800-627-0557.
Kate Farms can be contacted through https://myproductinformation.com/ or by calling 1-855-344-3027.
You can also call your state’s FDA complaint office to talk to someone about your experience.
- Pennsylvania: 877-689-8073
- New Jersey: 973-331-4998
- Delaware: 877-689-8073
Additional information about the bacteria mentioned above:
What is Cronobacter sakazakii and who can get sick?
Cronobacter sakazakii is found naturally in the environment and can live in dry foods, like powdered infant formula. Cronobacter can cause diarrhea and urinary tract infections in people of all ages. Young infants aged 2 months or younger are at greater risk of developing a severe infection. The first symptom of Cronobacter infection is usually a fever, accompanied by poor feeding, crying, or low energy. Infants should be seen promptly if these signs should develop. Other infants more likely to get sick are those born prematurely and those who are immunocompromised.
What is Salmonella newport and who can get sick?
Salmonella newport is a bacteria that can cause outbreaks of foodborne illness, like other Salmonella species. Salmonella species can cause diarrhea in people of all ages. Infants under 3 months of age are more at risk of developing more serious infections. As with Cronobacter, infants should be seen promptly if they develop fever, particularly if it is associated with decrease energy levels.
What is Clostridium botulinum and who can get sick?
Clostridium botulinum is found naturally in many places, but rarely makes people sick. The bacteria make spores that make a toxin, botulinum, that can cause severe food poisoning. Symptoms of botulism develop usually within 6-36 hours, but up to several days after ingestion. Symptoms of botulism include nausea, vomiting, diarrhea, poor muscle tone, difficulty swallowing, droopy eyelids, changes in vision, and breathing difficulties that can result in serious medical outcomes.