A version of this story was first published on Feb. 18, 2022. It has been updated.

An investigation by the Food and Drug Administration (FDA) has been expanded to now include four types of powdered baby formula all produced in a facility run by Abbott Nutrition in Sturgis, Michigan. 

On Feb. 28, according to the FDA, a new case of Cronobacter sakazakii infection in an infant was linked to exposure to Similac PM 60/40, a powdered infant formula also produced in the Sturgis facility. The agency says Cronobacter infection may have been a contributing cause of the infant's death.

"This case is under investigation, and at this time the cause of the infant’s Cronobacter sakazakii infection has not been determined. We want to extend our heartfelt sympathies to the family," Abbott states in a press release.

As of Feb. 17, there were four reported cases of infants being hospitalized with serious infections (three with Cronobacter sakazakii infection and one due to Salmonella Newport) after consuming powdered infant formula under the brands Similac, Alimentum or EleCare, all produced in the Sturgis facility. One death was reported due to Cronobacter infection.

Abbott Nutrition has issued a proactive voluntary recall of Similac and three other products.

4 Abbott Nutrition powdered formula products are included in the Similac recall

The initial infections occurred across three states, Minnesota, Ohio and Texas, between Sept. 6 and Dec. 12, 2021.

Do not use Similac, Alimentum and EleCare formulas if the following criteria is found on the container: 

  • The first two digits of the code are 22 through 37
  • The code on the container contains K8, SH, or Z2
  • The expiration date is 4-1-2022 (APR 2022) or later

Do not use Similac PM 60/40 if the following criteria is found on the container:

  • Lot # 27032K80 (can)
  • Lot # 27032K800 (case)

These codes and dates can be found on the bottom of the can as seen in the image below. Any can with that information has the potential to be contaminated with Cronobacter, the FDA says.

You can type in the code (lot number) on the bottom of the can on Abbott's website to see if your product has been recalled.

Sample Product Image from the FDA Investigation of Cronobacter and Salmonella Complaints about Powdered Infant Formula (February 2022)
Sample Product Image from the FDA Investigation of Cronobacter and Salmonella Complaints about Powdered Infant Formula (February 2022)

Abbott and the FDA state that products that do not contain the criteria above are not impacted and can still be used, including liquid formula products, other powdered formulas and metabolic deficiency nutrition formulas.

"We know parents depend on us to provide them with the highest quality nutrition formulas," says Joe Manning, executive vice president, nutritional products, Abbott, in a statement on Feb. 17. "We're taking this action so parents know they can trust us to meet our high standards, as well as theirs. We deeply regret the concern and inconvenience this situation will cause parents, caregivers and health care professionals."

Because formula products are often a primary or sole source of food for babies, bacterial contamination can be very dangerous. “We want to reassure the public that we’re working diligently with our partners to investigate complaints related to these products, which we recognize include infant formula produced at this facility, while we work to resolve this safety concern as quickly as possible,” says Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response in a press release on Feb. 17.

What to do if your product is affected by the Similac recall

According to Abbott, if your product is affected by the recall, do not use it and go to similacrecall.com for a refund or replacement, depending on how the product was acquired or the type of product.

Symptoms of Cronobacter and Salmonella infection

Cronobacter can cause severe illness primarily in infants, and is rare, but is a cause for immediate medical treatment. Cronobacter infection can cause bowel damage and may spread through the blood to cause sepsis or meningitis, which can be life-threatening. 

Symptoms of sepsis and meningitis may include: 

  • Poor feeding
  • Irritability
  • Body temperature changes
  • Jaundice (yellowing of the skin and eyes)
  • Grunting breaths
  • Abnormal movements

Salmonella is a type of bacteria that can cause stomach illness and fever. 

Symptoms of salmonella infection may include:

  • Diarrhea
  • Fever
  • Abdominal cramps

Severe cases may include a high fever, headache, lethargy, rash or blood in urine or stool.

If you notice any of these symptoms in your child, seek immediate medical treatment. If you believe your child may have been exposed to the formula products impacted by the advisory, reach out to your child’s pediatrician. 

Finding a formula that isn’t included in the advisory above may be difficult, as there is a reported formula shortage happening at the same time. The FDA stresses that caregivers should never dilute infant formula and shouldn’t make homemade formula to feed infants, either. Your pediatrician should be able to provide recommendations on finding formula or changing feeding practices if needed.