CSPI calls on Abbott and FDA to clarify the scope of the infant formula recall

Statement of CSPI Deputy Director of Regulatory Affairs Sarah Sorscher

Abbott and the Food and Drug Administration should clarify which infant formula products are part of a recall from Abbott’s Sturgis, Michigan facility, which is being investigated after five infant illnesses and two deaths that may have been caused by Cronobacter infection from contaminated formula.

Abbot first announced a recall covering products manufactured in the facility on February 17, 2022. That recall covered Similac, Alimentum and EleCare powdered formulas with lot codes beginning with the first two digits 22 through 37 that contained a K8, SH, or Z2, with an expiration date in April of this year or later.

On February 28, Abbott expanded the recall to include Similac PM 60/40 powdered infant formula with Lot # 27032K80 (can) and Lot #27032K800 (case), a product that confusingly appears to fall within the original recall as described on the Abbott and FDA websites. This recall was announced after an infant who had consumed formula from this lot contracted Cronobacter infection and died.

In addition, consumers have taken to social media with complaints that products that have lot codes and expiration dates within the recalled range do not appear as part of the recall when they enter information into the company’s recall website, similacrecall.com.

FDA initiated an inspection of the facility in Sturgis in late January, and found Cronobacter present in environmental samples. An agency review of the firm’s internal records also indicated environmental contamination with Cronobacter sakazakii and that Abbott had previously destroyed product due to the presence of Cronobacter.

Abbott and the FDA have failed to clearly communicate to consumers which products are covered by the recall and which are not.

Lastly, the latest “expansion” announcement suggests that Abbott may not have correctly identified all affected products from the facility in its original recall. Given the events of this outbreak and ongoing investigation to identify the source of the contamination, consumers deserve to know if there are any remaining products made in that facility that have not been recalled, and provided an explanation for why they are not affected by the contamination.

We urge Abbott and the FDA to clarify the scope of the infant formula recall, including being straight with consumers about which products made in Abbott’s Sturgis facility are part of the recall.