Posted: June 24, 2022
Earlier this year, a large manufacturer of infant formula, Abbot Nutrition, recalled some of their powdered infant formulas after some babies got sick from drinking the formula.

After an investigation, it was determined that the illness was caused by the bacteria Cronobacter sakazakii. Illness caused by this bacteria is rare, but it can cause a life-threatening infection in newborns. Babies sickened by Cronobacter may be irritable, have temperature changes, show signs of jaundice (yellowing of the skin and eyes), take grunting breaths, and not eat well. In severe cases, babies can experience meningitis (inflammation in the spine or brain) or experience sepsis (widespread infection throughout the body which can cause organ failure) (FDA, 2022b).
As a result of this recall, the factory has stopped production and all affected product has been removed from store shelves. Other manufacturers are ramping up production and infant formula supplies from other countries are being imported. Despite these efforts, caregivers still are having a hard time finding infant formula at the store. Shortages at the store have led some desperate consumers to find recipes on the internet to make homemade infant formula. The Food & Drug Administration (FDA) does not recommend making homemade infant formula (FDA, 2022a).
The first risk associated with making your own infant formula is food safety. Some recipes found on the internet and social media include raw cow or goat milk. Raw milk refers to milk that has not been pasteurized. Pasteurization is the process of quickly heating a food to a certain temperature for a certain period of time to destroy bacteria (germs) that cause illness. Raw milk can contain over ten disease-causing bacteria and has been associated with scores of food-borne illness outbreaks in recent decades (FDA, 2018).
In addition to the food safety risks, the second risk associated with making your own infant formula is serious health issues due to inadequate nutrition. Proper nutrition for babies under the age of 1 is vital to maintain their rapid physical growth and brain development (USDA & HHS, 2020). Current FDA regulations for infant formula require specific minimum amounts for twenty-nine nutrients and maximum amounts for nine of those nutrients (FDA, 2022). These include the appropriate amounts of carbohydrate, protein, fat, and linoleic acid and numerous vitamins and minerals, like sodium, potassium, and chloride. Formula mixtures made from recipes at home cannot replicate commercial formulas making them less digestible for infants and often do not provide the right amounts of necessary nutrients (Bertmann et al., n.d.). The Academy of Nutrition and Dietetics (Bertmann et al., n.d.) reports that homemade formula recipes may be:
- low in iron which can lead to iron deficiency anemia and potentially long-term issues with brain development and learning
- low in vitamins C & D. Vitamin D deficiency can lead to problems with bone development. Low vitamin C may lead to a host of health issues, including scurvy
- too high in vitamin A, which can cause liver damage
- too high in salt or other nutrients that can damage a baby's (not yet fully developed) kidneys which may lead to electrolyte imbalances and dehydration.
- difficult for babies to digest causing bowel changes and problems
- increasing the risk of food allergies by introducing some foods too early
The American Academy of Pediatrics (AAP) does not recommend using homemade baby formula (Abrams, 2022). "Parents and caregivers may not realize the potential harm that could occur from using homemade infant formula--putting a child's health, or even life, at risk" (Bertmann et al., n.d.).
What can you do? The formula shortage crisis can cause extra stress on parents and caregivers to access what they need nutritionally for their infant. During this shortage, the AAP reinforces the point that formula brands may be substituted for other similar brands or store brands if the infant does not have allergies. There are a few different formula categories including: cow-milk based, soy-based, elemental amino-acid, preterm, and special. It is usually acceptable for most babies to switch to any available formula within that category, including generic or store brands. Know what class of formula your baby tolerates well so you can make an informed substitution choice. Babies may have temporary fussiness or stool changes while they get started and acclimated to a new formula. If your baby is on a hypoallergenic formula, talk with your pediatrician about suitable substitutions.
Here are a few other tips from the American Academy of Pediatrics to consider during this shortage (Abrams, 2022a):
- Do not water down formula to "stretch" your formula supply. This can be dangerous as babies will not be getting adequate nutrients which can cause serious health problems. Mix formula with the correct amount of water according to the manufacturer's directions.
- Do not switch to cow's milk prior to the recommended 12 months of age as it is difficult to completely digest and is higher in protein which can stress the baby's kidneys and lead to health problems. Cow's milk also does not contain enough iron which can lead to anemia.
- Do not use plant-based beverages like almond, hemp, coconut, or soy (sometimes labeled as milk) as they do not provide the required protein and minerals, so should not be used before 1 year of age.
- Toddler formulas are also not recommended under 1 year as they are not regulated by the FDA. In an emergency, they could be used for a few days if a baby is close to their first birthday.
- Stay in close contact with your child's healthcare provider, especially for assistance with acquiring formula. They may be able to help you find a local supply of formula or provide samples.
- Check smaller stores and pharmacies that may have a supply of formula. You can also talk to the pharmacist to see if they can order smaller lots.
- Shop online from well-recognized sites rather than individually sold or at auctions which may sell expired or lower-quality products.
- Do not purchase formula from overseas which has not been reviewed or approved by the FDA and may not meet nutritional and safety standards. Also, do not use recalled or expired formulas. Be sure to check the expiration dates and recall information of any product you may receive from food pantries or other food donation sources.
- Stay tuned in to local social media groups of other parents for formula availability. Try WIC and 2-1-1 (United Way).
References
- Abrams, S. A. (2022). With the baby formula shortage, what should I do if I can't find any? HealthyChildren.org. Retrieved June 1, 2022
- Abrams, S. A. (2022a). Is homemade baby formula safe? HealthyChildren.org. Retrieved June 2, 2022
- Bertmann, C. F., Dunn, and C. G., Racine, and E. F., & Fleischhacker, and S. (n.d.). Health risks of homemade infant formula. EatRight. Retrieved June 10, 2022.
- FDA (U.S. Food & Drug Administration). (2022). Infant formula guidance documents & regulatory information. Retrieved June 8, 2022
- FDA (U.S. Food & Drug Administration). (2022a). Infant formula: Safety do's and don'ts. Retrieved June 6, 2022
- FDA (U.S. Food & Drug Administration). (2022b). Powdered infant formula recall: What to know. Retrieved June 8, 2022
- FDA (U.S. Food & Drug Administration). (2018). Raw Milk Questions & Answers. Retrieved June 8, 2022
- USDA & HHS (U.S. Department of Agriculture & U.S. Department of Health and Human Services). (2020). Dietary Guidelines for Americans, 2020-2025.
By Katherine French, MS, RD, LDN, Education Program Specialist, Penn State Better Kid Care and Andy Hirneisen, MA, Senior Food Safety & Quality Educator, Penn State Extension