For immediate release:

Updates:

August 1, 2022: Certain specialty and metabolic formulas have been tested and released by Abbott Nutrition on a case-by-case basis. Parents and caregivers of infants receiving this specialty and metabolic formula should not reference the recalled product description above, but instead should enter the product lot code found on the bottom of their packaging using the ” Check the batch number » at the bottom of the company file. web page or by calling Abbott Nutrition at 1-800-881-0876.

On February 28, the CDC announced another Cronobacter sakazakii illness with exposure to powdered infant formula produced at Abbott Nutrition’s facilities in Sturgis, Michigan. Cronobacter infection may have been a contributing cause to this patient’s death. In total, this investigation includes four reports of Cronobacter sakazakii infections in infants (three following FDA complaints and one following a CDC case finding) and one complaint of Salmonella infection. Newport in an infant. All five illnesses (four Cronobacter infections and one Salmonella Newport infection) resulted in one hospitalization and Cronobacter may have contributed to the deaths of two patients.

The most recent patient would have consumed Abbott Nutrition’s Similac PM 60/40 product with lot code 27032K800 prior to Cronobacter sakazakiiI infection. The FDA and CDC notified the company of these findings and on February 28, 2022, Abbott Nutrition voluntarily recalled Similac PM 60/40 powdered infant formula with lot code 27032K800. This is a special formula for certain infants who would benefit from reduced mineral intake and was not included in the previous recall. Currently, Similac PM 60/40 with lot code 27032K80 (box) / 27032K800 (case) are the only types and lots of this specialty formula being recalled.

On Feb. 17, Abbott announced that the company had initiated a voluntary recall of potentially affected products, including Similac, Alimentum and EleCare powder formulas manufactured at its Sturgis, Michigan plant. Products made in this factory can be found across the United States and have likely been exported to other countries as well. Canadian health authorities have also issued a recall warning. Additional recall information is available on the FDA website. Parents and caregivers can also enter their product lot code on the company’s website to check if it is part of the recall.

The FDA is continuing to investigate and will update this advisory if additional consumer safety information becomes available: FDA Investigation of Cronobacter and Salmonella Complaints: Powdered Infant Formula (February 2022) | FDA.

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Today, the United States Food and Drug Administration announced that it is investigating consumer complaints about Cronobacter sakazakii and Salmonella Newport infections. All cases reportedly consumed powdered infant formula produced at Abbott Nutrition’s facilities in Sturgis, Michigan. Following ongoing investigation, in collaboration with the U.S. Centers for Disease Control and Prevention and state and local partners, FDA is warning consumers to avoid purchasing or using certain powdered formulas infant formula produced at this facility. This is an ongoing investigation and the company is working with the FDA to initiate a voluntary recall of the potentially affected product.

The FDA advises consumers not to use Similac, Alimentum, or EleCare powdered infant formula 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.

The FDA is investigating complaints of four childhood illnesses in three states. The four cases related to these complaints were hospitalized and Cronobacter may have contributed to a death in one case. The FDA has initiated an on-site inspection at the facility. Results to date include several positive outcomes Cronobacter sakazakii results of environmental samples taken by the FDA and adverse inspection observations by FDA investigators. A review of internal company records also indicates contamination of the environment by Cronobacter sakazakii and destruction of the product by the company due to the presence of Cronobacter.

“As this is a product used as the sole source of nutrition for many newborns and infants in our country, the FDA is deeply concerned about these reports of bacterial infections,” said Frank Yiannas, Deputy Commissioner of the FDA for food policy and response. “We want to reassure the public that we are working diligently with our partners to investigate complaints related to these products, which we acknowledge include infant formula produced at this facility, as we work to resolve this issue of safety as quickly as possible.

Further information:

  • Products made at the Sturgis, Michigan plant can be found throughout the United States and have likely been exported to other countries.
  • Products that do not contain the information listed above are not affected. The FDA advisory does not include liquid formula products or metabolic deficiency nutritional formulas. Consumers should continue to use all products not covered by the advisory.
  • To date, this investigation has been associated with four diseases (three per Cronobacter and one for Salmonella) covering the following states: MN, OH and TX. The four cases related to these complaints were hospitalized and Cronobacter may have contributed to a death in one case.
  • Cronobacter bacteria can cause serious and life-threatening infections (sepsis) or meningitis (inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis can include poor diet, irritability, temperature changes, jaundice (yellowing of the skin and whites of the eyes), grunting in the breath, and abnormal movements. Cronobacter the infection can also cause intestinal damage and spread through the blood to other parts of the body.
  • Parents and caregivers of infants who have used these products and who are concerned about their child’s health should contact their child’s healthcare provider. If your child has any of these symptoms, you should tell your child’s health care provider and seek medical attention for your child immediately.
  • Salmonella are a group of bacteria that can cause gastrointestinal illness and fever called salmonellosis. Most people with salmonellosis develop diarrhea, fever, and abdominal cramps. More severe cases of salmonellosis can include high fever, body aches, headache, lethargy, rash, blood in urine or stool, and in some cases can be fatal.
  • Parents and caregivers should never dilute infant formula and should not make or give infants homemade infant formula.
  • If your regular formula is not available, contact your child’s healthcare provider for recommendations on changing feeding practices.

The FDA is continuing its investigation and will provide additional consumer safety information as it becomes available.

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The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.