Abbott Recalls Powdered Infant Formula from Single Manufacturing Site

Abbott Recalls Powdered Infant Formula from Single Manufacturing Site

Last evening, Abbott Nutrition announced a voluntary recall of infant powdered formula manufactured at their Sturgis facility in Michigan, including Similac, Alimentum, and EleCare. This recall comes after four consumer complaints related to Cronobacter sakazakii and Salmonella. Parents and caregivers of infants who have used these products and have concerns about the health of their child should contact the child’s health care provider.

The U.S. Food and Drug Administration (FDA) alerted consumers to avoid purchasing and using infant powdered formula from Abbott Nutrition’s Sturgis, Michigan facility. The FDA is also investigating these consumer complaints of infections and has initiated an onsite inspection of the facility.

The FDA is advising consumers not to use Similac, Alimentum, or Elecare powdered infant formulas if the following is included in the product’s lot number:

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

Abbott has also developed a web-based tool to determine if the consumer’s product was included in this recall. Consumers can click here to check their product’s lot number, located at the bottom of their product.

Please note that this is a targeted recall and does not affect all Abbott products. The recall does not include liquid formula products or any metabolic deficiency nutrition formulas. The FDA states that consumers should continue to use all products not covered by the advisory. As NWA and WIC providers have consistently echoed during the COVID-19 pandemic, the FDA advises parents and caregivers to never dilute infant formula and to never make or feed homemade infant formula to infants.

Thus far, consumer complaints included four instances of infant illnesses across three states, including Minnesota, Ohio, and Texas. In all four cases, infants were hospitalized and Cronobacter may have contributed to death in one case. Abbott product manufactured in Michigan was distributed across the country. Cronobacter bacteria can cause life-threatening infections like sepsis or meningitis. Symptoms may include poor feeding, irritability, temperature changes, jaundice, grunting breaths and abnormal movements. Salmonella are a group of bacteria that can cause gastrointestinal illness and symptoms like diarrhea, fever, and abdominal cramps.

WIC providers must be prepared to address participant concern and confusion, while also working with vendor partners to address the needs of WIC families. Even before this recall, WIC providers have reported supply chain disruptions that have affected access to infant formula, and retailers may even further limit purchases due to limited stock. In the coming weeks and months, NWA will work with WIC providers to inform WIC participants of this recall and exercise all necessary flexibilities to ensure that WIC families have access to safe, adequate, and consistent options that support the nutrition needs of infants.

Continuing Resolution Passes, March 11 to Pass Omnibus and Extend WIC Benefit Bump

The Senate has passed a House-passed continuing resolution that will extend federal funding through March 11. This step averts a government shutdown by extending federal funding and assures that appropriators will have adequate time to finalize an omnibus spending agreement, after a bipartisan framework was agreed to last week. The omnibus agreement will not only sustain funding, but ideally extend the WIC benefit bump for fruits and vegetables through September 30, 2022. NWA will continue to uplift the importance of passing a full spending agreement by March 11 that is inclusive of full funding for WIC and extends the enhanced WIC cash value benefit for fruits and vegetables.

Robert Califf Confirmed as FDA Commissioner

This past Tuesday, Robert M. Califf, was confirmed (50-46) as commissioner of the Food and Drug Administration (FDA) and was sworn into the role yesterday. Dr. Califf, a cardiologist, also served as Commissioner of FDA from 2016-2017. Acting commissioner Janet Woodcock will now transition to FDA’s principal deputy commissioner.

NWA looks forward to continuing working in partnership with FDA under Dr. Califf’s leadership. This is a critical time for FDA and the health and safety of Americans as our country navigates pediatric approvals of the COVID-19 vaccine, safety of our nation’s food supply, and environmental health concerns impacting infant formula and infant foods.

Biden Administration Proposes New Public Charge Rule

Yesterday, the U.S. Department of Homeland Security (DHS) proposed regulations that mirror the historic interpretation of public charge, consistent with field guidance that has been in place since 1999. The Trump administration had sought to expand this narrow grounds to deny legal status to immigrants, culminating in a 2019 final rule that would have jeopardized an individual’s status if they accessed Medicaid, SNAP, or housing subsidies. This effort resulted in a significant chilling effect that persists today, as immigrant and mixed-status families withdrew from federal assistance programs, including WIC.

The proposed rule releases yesterday narrowly defines the federal programs that could implicate public charge, limited to direct cash assistance and long-term institutionalization. This interpretation is consistent with the 1999 field guidance that was in place before the Trump administration’s efforts. Nutrition programs like WIC and SNAP would not be considered in public charge determinations.

The new DHS proposal will have a 60 day comment period. NWA will be submitting comment in support of these changes. For more information on providing public comment and this issue, please reach out to NWA’s State Public Policy Associate, Noora Kanfash, at nkanfash@nwica.org.