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Dec 26, 2023

FDA Warns Consumers Not to Use Certain Powdered Infant Formula Produced in Abbott Nutrition’s Facility in Sturgis, Michigan

FDA News Release Updates: August 1, 2022: Certain specialty and

FDA News 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 recall product description above, but instead should enter the product lot code found at the bottom of their package by using the "Check Lot Number" feature at the bottom of the company's webpage or by calling Abbott Nutrition at 1-800-881-0876.

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

The most recent patient was reported to have consumed Abbott Nutrition's Similac PM 60/40 product with the lot code 27032K800 prior to Cronobacter sakazakiiI infection. The FDA and CDC informed the firm of these findings and on Feb. 28, 2022, Abbott Nutrition voluntarily recalled Similac PM 60/40 powdered infant formula with the lot code 27032K800. This is a specialty formula for certain infants who would benefit from lowered mineral intake and was not included in the previous recall. At this time, Similac PM 60/40 with lot code 27032K80 (can) / 27032K800 (case) are the only type and lots of this specialty formula being recalled.

On Feb. 17, Abbott announced that the company initiated a voluntary recall of potentially affected products, including Similac, Alimentum and EleCare powdered formulas manufactured in its Sturgis, Michigan facility. Products made at this facility can be found across the U.S. and were likely exported to other countries as well. Canadian health officials 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.

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

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Today, the U.S. Food and Drug Administration announced it is investigating consumer complaints of Cronobacter sakazakii and Salmonella Newport infections. All of the cases are reported to have consumed powdered infant formula produced from Abbott Nutrition's Sturgis, Michigan facility. As a result of the ongoing investigation, along with the U.S. Centers for Disease Control and Prevention and state and local partners, the FDA is alerting consumers to avoid purchasing or using certain powdered infant formula products produced at this facility. This is an ongoing investigation, and the firm is working with the FDA to initiate a voluntary recall of the potentially affected product.

The FDA is advising consumers not to use Similac, Alimentum, or EleCare powdered infant formulas if:

The FDA is investigating complaints of four infant illnesses from three states. All four cases related to these complaints were hospitalized and Cronobacter may have contributed to a death in one case. The FDA has initiated an onsite inspection at the facility. Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. A review of the firm's internal records also indicate environmental contamination with Cronobacter sakazakii and the firm's destruction of product due to the presence of Cronobacter.

"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."

Additional Information:

The FDA is continuing to investigate and will provide additional consumer safety information when it becomes available.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

08/01/2022

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