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On Feb. 17, the U. S. Food and Drug Administration (FDA) issued a warning regarding infant formula manufactured by Abbott Nutrition from its Sturgis, Michigan facility. Cronobacter sakazakii and Salmonella Newport infections were reported among four infant illnesses within three states. The common element linking these cases was the powdered formula, however, it is important to note that this has not been determined to be the cause of the infections.

All four infants – from Minnesota, Ohio and Texas – were hospitalized; three with cases of Cronobacter and one with Salmonella Newport. Cronobacter may have contributed to one infant’s death among the four cases, according to a news release.

“As this is a product used as the sole source of nutrition for many of our nation’s newborns and infants, the FDA is deeply concerned about these reports of bacterial infections,” said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response. “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.”

Formulas included in this recall

Abbott announced a voluntary recall of Similac, Alimentum and EleCare powdered infant formulas with the following lot number criteria:

  • The first two digits of the code are 22 – 37; AND
  • The code on the container contains K8, SH, or Z2; AND
  • The expiration date is 4-1-2022 (APR 2022) or later.
This includes:
  • All Similac Total Comfort and Spit-Up, Alimentum and Electra (Infant and Jr) powders
  • Some Similac Advance and Sensitive powders
This does NOT include:
  • Isomil and Neosure
  • Liquid formulas (ready-to-feed as well as concentrate)

A web-based tool can be used to identify products included in this recall.

This is a targeted recall; only products manufactured in the Sturgis facility, with the corresponding lot numbers are included.

This recall does not include any liquid formula products or metabolic deficiency nutrition formulas. The FDA has stated that all other products produced by Abbott are safe to continue use.

“We value the trust parents place in us for high quality and safe nutrition and we’ll do whatever it takes to keep that trust and resolve this situation,” said an Abbott representative in a statement. The investigation regarding the illnesses is still ongoing.

The CDC warns against diluting infant formula as well as making or feeding homemade formula to infants.

Recalled product

If you have purchased formula included in this recall, do not throw the container away. The DHS advises those with affected products to return them for a refund or replacement. Some stores may limit the number of cans individuals are able to exchange due to product availability.

Contact your local WIC office for assistance if you are unable to exchange your items.

WIC recipients

Those who receive infant formula through WIC are being advised to return the recalled product to the store where it was purchased to receive a refund or exchange. For those in need of further assistance, they may call 1-800-986-8540. The WIC program allows for a different brand of formula to replace the affected brands.

Cronobacter sakazakii

While infections are rare, Cronobacter can cause sepsis, a dangerous blood infection, or meningitis, which causes swelling in the brain and spinal areas.

Infants 2 months and younger are most likely to become sick with meningitis due to Cronobacter infection. Other infants who are most at-risk are those with compromised immune systems due to illness or treatments such as chemotherapy.

Symptoms

The first symptom of a Cronobacter infection is typically a fever, followed by poor feeding, crying or very low energy. Some babies, however, may experience seizures. Any of these symptoms present warrants a trip to the doctor for those who may have used these products.

Other symptoms may be irritability, temperature changes, jaundice (yellowed skin and whites of eyes), grunting breaths and abnormal movements, according to the FDA.

Salmonella

Salmonella includes an entire group of bacteria that cause gastrointestinal illness and fever called salmonellosis.

Symptoms

Most people will develop diarrhea, fever and abdominal cramps. More severe cases could include high fever, body aches, headaches, lethargy, rash, blood in urine or stool, and in some cases, death.

*This post has been updated to reflect that the powdered infant formula was not determined ultimately to be the cause of infections, but rather a common link between cases. Abbott's recall was voluntary as a precaution.

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