Picture

Spanish

If you are using powdered infant formula, be aware that certain Similac, Alimentum and EleCare products have been recalled and should not be used.

The US Food and Drug Administration (FDA) is investigating consumer complaints of bacterial infections in four infants who consumed powdered infant formula produced at Abbott Nutrition’s facilities in Sturgis, Michigan. All four infants required hospitalization and bacterial infection may have contributed to the deaths of two patients.

The FDA has released a full list of recalled brands. The recalled products should no longer be available for sale. But if you have these products in your home, check the lot code on the bottom of the package to determine if they are included in the recall.

The FDA also provides additional information for parents and caregivers of infants receiving medical specialty infant formulas and people using certain medical foods.

Because infant formula is the only source of nutrition for many newborns and infants, the FDA understands and shares the concerns that parents and caregivers may have.

Here is some information to help you continue our investigation.

Which powdered infant formula products have been recalled?

Abbott Nutrition has recalled certain powdered infant formula produced at its plant in Sturgis, Michigan. Products from this factory can be found across the United States and some have been exported to other countries. Here’s how you can tell if you have one of these products.

The FDA recommends consumers look at the lot code, a multi-digit number on the bottom of a container of Similac, Alimentum, and EleCare powdered infant formula, and not use it if:

  • the first two digits of the code range from 22 to 37; and
  • the code on the container contains K8, SH or Z2; and
  • the expiry date is 4-1-2022 (April 2022) or a later date.

In addition to the products described above, Abbott Nutrition has recalled Similac PM 60/40 with a lot code of 27032K80 (box) / 27032K800 (case).

You can also enter your product lot code on the Company Website to check if it is part of the recall. Please see the images below for a closer look at the identifying information.

Abbott powder products that do not have the code and expiration date listed above are not included in the recall. Liquid formulas are not included in the recall. Similac PM 60/40 with lot code 27032K80 (box) / 27032K800 (case) are the only types and lots of this specialty formula being recalled at this time.

Top of Infant Formula can show numeric coding.
Top of powdered infant formula box, showing dates and number coding.
Bottom of powdered infant formula container

What infections have been reported and what symptoms should I look for?

All four cases involve Cronobacter sakazakii infection.

  • Cronobacter the bacteria can cause serious and life-threatening infections (sepsis) or meningitis (inflammation of the membranes that protect the brain and spine). Cronobacter infections are rare but pose a particularly high risk to newborns.
  • Symptoms related to Cronobacter infection include: poor diet, irritability, temperature changes, jaundice, grunting breath or abnormal body movements.
  • If your baby has symptoms related to Cronobacter infection, contact your child’s healthcare provider to report symptoms and get immediate care.

When and where were the diseases?

Illnesses occurred in Minnesota, Ohio and Texas between September 6, 2021 and January 4, 2022.

I’m having trouble finding the formula. What is the FDA doing to help?

We are aware that the recall has created new concerns about the availability of certain types of infant formula, particularly given the global strains on supply chains experienced during the COVID-19 pandemic.

The FDA is working with Abbott Nutrition to better assess the impacts of the recall and understand the production capacity of other Abbott facilities that produce some of the affected brands. We are also working with Abbott on the safe resumption of production at the Sturgis, Michigan plant. As Abbott Nutrition launched its recall, the FDA intensified contact with other infant formula manufacturers to inquire about their capacity and potential impacts. We will continue discussions with Abbott Nutrition and other infant formula manufacturers and review all available tools to support infant formula supply.

Are homemade formulas an alternative?

No. The FDA advises parents and caregivers not to prepare or give homemade infant formula. Homemade infant formula recipes have not been reviewed by the FDA and may be lacking in nutrients essential for an infant’s growth.

What should I know about medical specialty infant formula and certain medical foods?

The Abbott Nutrition facility that produces the recalled infant formula also produces metabolic infant formula and other medical specialties for infants with inborn errors of metabolism and other medical needs, as well as medical foods. These products, with the exception of one lot of Abbott Similac PM 60/40, were not recalled because the FDA determined that the risk of not having these specialty products available would significantly worsen the underlying medical conditions. . For many of these patients, the risk of life-threatening adverse events from restricted access to these much-needed products likely outweighs the risk from consuming products produced in the facility.

The FDA wants to make sure that parents and caregivers who use these specialty products are aware that there may be a risk of Cronobacter contamination. If possible, parents and caregivers should work with their healthcare provider to determine if comparable products may be appropriate. If comparable alternative products are not available or appropriate, parents and guardians should take extra care to follow the The CDC’s updated guidance for parents on how to reduce the risk of Cronobacter contamination of preparation when preparing the powdered product, whether this contamination comes from the product itself or from other sources of contamination in the home.

Examples of medical and specialty products include Glutarex-1, Glutarex-2, Cyclinex-1, Cyclinex-2, Hominex-1, Hominex-2, I-Valex-1, I-Valex-2, Ketonex-1, Ketonex- 2, Phenex-1, Phenex-2, Phenex-2 Vanilla, Pro-Phree, Propimex-1, Propimex-2, ProViMin, Calcilo XD, Tyrex-1, Tyrex-2 and Similac PM 60/40.

It is important to note that these specialty infant formulas and medical foods are not sold in traditional retail stores. These products often require a prescription and are sold through specialty pharmacies and other specialty distribution channels such as medical product suppliers.

Parents and caregivers of infants and children using these products should contact their child’s health care providers if they have any questions about the use of these products.

What else should I know?

Parents and caregivers should also not dilute infant formula. Consumers should also avoid buying infant formula online from outside the United States, as it may be counterfeit.

If your regular formula is not available, contact your child’s healthcare provider for recommendations on changing feeding practices.

If you pass formula milk WIC, do not discard the formula. Instead, you should take it to the store for a refund and exchange or call the company at 1-800-986-8540 for assistance. WIC recipients should be able to obtain another brand with a similar formula. Call your local WIC clinic for more advice.

Additional Resources: