Making infant formula is a complex process but reporting fairly and with a balanced perspective shouldn’t be. That’s why we are sharing our response to ProPublica below, so that parents, media and other stakeholders have the facts.

Abbott’s Written Response to ProPublica

To begin, Abbott stands behind the quality and safety of all our products including those made at Sturgis. The company had already reviewed the allegations that appear in your questions and had determined that they are either untrue or misleading. We address them below. We also provide important context and details on two of your questions related to quality and ingredients. But first, we need to set the record straight on the events of 2022 and what has transpired since.

Setting the Record Straight on Sturgis

In February 2022 Abbott Nutrition voluntarily recalled nearly all infant formula manufactured at Sturgis.

• At that time, four infants in the U.S. had been ill over a course of several months due to 3 cases of Cronobacter sakazakii and one of Salmonella Newport. Cronobacter is a ubiquitous bacteria that is known to harbor in homes (especially kitchens), bottled water, and un-sanitized feeding equipment (like breast pumps); as well as all infant formula manufacturing facilities.
• The U.S. Food and Drug Administration (FDA), seeking to pinpoint a potential source of the four infections, inspected Sturgis because all four infants had consumed Abbott formulas made there at different times over the course of nearly a year. While there, FDA found Cronobacter sakazakii in the environment in four non-product contact areas of a 788,000-square-foot facility (the equivalent of nearly 14 football fields). 
• In the absence of complete information, and before full genetic sequencing of the clinical infant cases could be complete, Abbott voluntarily agreed to halt production at the facility and recall product made there. We immediately shut down the plant, sanitized it and began addressing the concerns raised by FDA during its inspection. 
• Additionally, when a fifth infant was identified, Abbott Nutrition voluntarily initiated a second recall of the specialty products since information and testing results were not available.
• Before we shut down Sturgis, we informed FDA there would be a shortage if the plant would be idled for an extended period. This is in part due to the volume of production there as well as hoarding behaviors that had started pre-Covid. As we predicted, the U.S. then suffered an infant formula shortage.
• We retain samples from all lots of all products we distribute. The samples from the lots that corresponded to those that were consumed by the infants were all tested. And all tested negative.
• Genetic sequencing on the available samples from two of the ill infants did not match the strains of Cronobacter found in the plant. Nor did the available samples from the infants match one another, indicating that the two cases did not have a common source. That’s important because microbiologists tell us that the DNA sequence is a critical element for determining origin. Institutions performing the testing of the other three infants did not retain or provide the clinical sample for Whole Genome Sequencing (WGS). The lack of this data is not a miss from Abbott Nutrition.
• Additionally, there is a publicly documented instance of another manufacturer not recalling product when clinical samples of Cronobacter in two separate infants did not match either and the factory sealed containers of powdered formula from the same lot numbers tested negative.
• On March 9, 2022, FDA informed us of the results from the government’s testing of the product that was taken from all five infant homes.
• In all five cases, the state, FDA, and/or CDC tested samples of the Abbott formula that was used by the child. In all five cases, all unopened containers tested negative.
• Open containers from the homes of the infants were also tested in four of the five cases; three of the four tested negative. The one positive was from an open container from the home of the infant, and it tested positive for two different strains of Cronobacter sakazakii, neither of which were found in the Sturgis plant. In fact, one matched the strain that caused the infant’s infection, and the other matched a strain found on a bottle of distilled water in the home used to mix the formula.
• This is significant because it was these five complaints that ultimately were the reason for the recalls.
• Further, FDA testing of product batches and retain product samples collected from the Sturgis facility during the inspection were all negative for Cronobacter and Salmonella.
• We later learned in March 2023 through a CDC report that Cronobacter sakazakii was recovered from breast pump parts used in the home of one of the four infants the FDA  was investigating in 2022.
• To be clear, no unopened distributed Abbott infant formulas have ever tested positive for Cronobacter sakazakii or Salmonella Newport.
• A study published in July 2024 in the American Society for Microbiology’s Applied and Environmental Microbiology journal showed that out of 263 households in the U.S., 36% had at least one environmental positive swab for Cronobacter spp. and 25% had Cronobacter sakazakii, confirming its ubiquity. And those findings were based on an average of just 10* swabs per house.
• If you want additional background, we suggest you review a video (link here) posted by the National Academies, in which CDC scientists look back on the Sturgis recall; in particular, Dr. Julia Haston’s presentation beginning at approximately 1:03, in which she explains, among other things:
  • The cases did not meet the definition of an “outbreak.”
  • There was “no definitive link” between the Sturgis facility and the cases investigated.
  • One of the four cases was “linked to PIF [powdered infant formula] that was likely contaminated in the home after the formula was opened.”
  • CDC’s investigation found five invasive Cronobacter infections unrelated to the Sturgis facility.
  • Powdered infant formula investigations “most often suggest that contamination [with Cronobacter] occurs in the home.”
  • “For Cronobacter, most cases linked to infant formula are not associated with an outbreak.”

Site Condition

The Sturgis site had a strong inspection history until September 2021 with zero observations by FDA in 13 inspections throughout the prior eight years (2012-2019).

• 6/12/12 - 0 Observations
• 10/10/12 - 0 Observations
• 6/17/13 – 0 Observations
• 12/3/13 - 0 Observations
• 6/16/14 - 0 Observations
• 9/8/15 - 0 Observations
• 12/9/15 - 0 Observations
• 3/24/16 - 0 Observations
• 9/11/17 - 0 Observations
• 10/25/17 - 0 Observations
• 9/10/18 - 0 Observations
• 5/6/19 - 0 Observations
• 9/16/19 - 1 Observation
• 9/20/21 - 5 Observations

This facility also received a Shingo Prize in 2019 for operational excellence given by the Shingo Institute to sites that demonstrate exceptional culture that foster continuous improvement.

We acknowledge that every site can improve, but we vehemently disagree with the characterization that Sturgis was “egregiously unsanitary” by people who never visited the site.

Abbott has addressed all FDA observations from 2021 and 2022. Since 2022, there have been no FDA observations or 483s.

Whistleblower

• A whistleblower is someone who raises issues with management that are ignored. This was not the case with the former employee who was termed a whistleblower in 2022. Instead, this former employee was dismissed due to serious violations of Abbott’s food safety policies, and after dismissal, through their attorney, made evolving, new and escalating allegations to multiple authorities.
• The former employee’s claims against Abbott with state and federal OSHA authorities were at first dismissed, and then abandoned. The Office of Criminal Investigation from the FDA (OCI) investigated the complaint and did not find it credible. And after the FDA spent 30 days at Sturgis in early 2022, the observations issued by FDA did not support any of the allegations.
• Yet media and a host of other stakeholders treated these allegations as truth and repeated them.

Water/Leaks

• Water is used in the manufacture of powdered infant formula at multiple steps in the process. As a result, in a facility the size of Sturgis, with literally miles of pipes, leaks, drips, and condensation are inevitable. What matters is how you respond to them. 
• We have a protocol for identifying and addressing water and leaks. A cross-functional team – comprised of food safety members from sanitation, microbiology, and responsible operational areas – deploys quickly to contain and control leaks, if and when they occur. Once contained, the team swabs and sanitizes the area to understand risk to the environment. Subsequently, leak remediation occurs and additional microbiological samples are taken to ensure a clean state. 
• Water and other liquid coolants are circulated through miles of piping that help cool and store infant formula both during and after manufacture.
• Therefore, it is impossible to remove water from a powdered infant formula plant. It will occasionally appear on floors, on equipment and as condensation. The goal is to limit any standing water and sanitize regularly to prevent/limit bacterial growth.

Abbott Actions Since 2022

Abbott has taken significant action in Sturgis to address FDA’s concerns, the Consent Decree requirements and to further enhance our formulas and support our employees. These include:

• Increased the number of employees at the site by more than 300 people.
• Increased training of all employees in conjunction with Consent Decree requirements.
• Made a number of organizational changes, including a new site director.
• Made continual investments in capital improvements and quality process enhancements; in fact, we have invested $60 million from 2022-2024 at Sturgis.

We communicate with FDA on a weekly basis, sharing environmental monitoring results and other information and we share finished product and in process testing results every month. Sturgis is also subject to ongoing independent third-party quality expert inspections. In fact:

• Sturgis has been inspected by the FDA 12 times since May 2022.
• And there is continued presence of an independent third-party quality and food safety consultancy with multiple consultants present at Sturgis every week. They are involved in routine oversight, food safety, sanitation, environmental monitoring program reviews, consulted regularly, participate in managerial meetings and walk the floor to ensure compliance with Good Manufacturing Practices (GMP).
• In addition to FDA inspections, the independent third party has done four full independent audits since January 2023.

Based on work with FDA and the independent third party, we have implemented several new processes, including:

• Enhanced our High, Medium and Low care plant environmental zoning designations, in which we created a new Zone Transition Procedure that provides additional requirements on how we traverse from one hygiene area to the other to further limit potential for pathogen transfer.
• We test six times the number of finished product samples (each from a different can) required by the federal regulation for Cronobacter sakazakii and three times the number for salmonella.
• In a typical month, Abbott takes thousands of environmental swabs across the plant – often greater than 10,000 per month, to check for microbes. 
• The Environmental Monitoring plan was specifically reviewed and approved by FDA as part of the Consent Decree process.

Finished product is not released until it passes:

• Microbial testing for both Cronobacter and Salmonella
• An analytical and microbiological testing results review
• Review of sanitation records related to every batch
• A final batch record audit and certification

We believe Sturgis is the most inspected, tested, and swabbed infant formula manufacturing facility in the U.S., and likely in the world. 

Since 2022, every major infant formula company in the U.S. has instituted recalls for Cronobacter sakazakii.

Looking back, we believe 2022 did not need to be a crisis of the proportion it was.

Volumes at Sturgis

In 2024, Abbott made 41% less infant formula at Sturgis than it did in 2021. Any assertion that quality is being sacrificed at the expense of volume and profit is patently untrue.

Quality Issues Raised in Your Questions

Abbott had already reviewed allegations that appear in your questions. We are addressing two quality-related questions:

• Alleged use of cardboard to funnel coconut oil: Cardboard was never taken from a dumpster – in fact, there are no dumpsters in the room where this occurred – nor was cardboard used to siphon oil. 
  • In one instance during the addition of oil which was spurting from a tote, a piece of cardboard was reactively used to prevent spilling onto the floor by directing and controlling the flow into the designated station before processing. This was done before heat treating (pasteurization) and straining and filtering.
  • The product met all finished testing requirements, including significant additional testing. We acknowledge that this is outside of our quality process, and this has been addressed. 
  • Crucially, this occurred very early in the manufacturing process, prior to both pasteurization to kill microbes and before straining to filter any extraneous material. 
  • The product met all finished testing requirements.  In fact, enhanced testing on this batch included 900 samples from 900 cans – all negative. 
  • There have been no medical complaints related to this lot.
• Alleged use of expired amino acids:
  • No amino acid past expiration date was used in the manufacture of any product. The amino acid expiration date was extended in conjunction with Good Manufacturing Processes, which is allowed under certain specifications. The process of extending shelf life of ingredients is also a commonly accepted practice in pharmaceutical manufacturing. The site had an independent third-party test and confirm amino acid nutrient levels. This third-party testing confirmed the amino acid met all specifications and nutrient levels.
  • Two containers of amino acid premix were placed on hold due to crustiness, were never used in the manufacturing process and were later destroyed.
  • However, when we find products that don’t meet all specifications, we dispose of them. For example, near the time that the above occurred, a batch of Phenex 2 Powder failed sensory testing due to an unrelated issue with base powder blended into the product, leading to destruction of the batch and base powder.

When Facts Aren’t Fully Known

It’s unclear whether the individuals who have given you information have any direct knowledge or expertise on these topics. But we’ve been down this road before.

For three years, we have watched individuals use Sturgis as a tool to advance their own agendas, gain fame or deflect from their own responsibility or actions. The media and others have repeatedly and unquestionably taken these people at face value without scrutinizing their actions or motivations.

For example, in 2022 media reports perpetuated an allegation that Abbott was testing empty cans of powdered infant formula (instead of cans filled with product), and the source of this unfounded allegation was a former employee without the appropriate knowledge of our quality processes. The truth was that we were performing bubble leak testing to check the integrity of the seals of the can, and in order to do that, we had to empty the can of its contents, submerse it in water, and then look for leaks.

Without expertise and the proper context, people are drawn to false conclusions, and those conclusions unfortunately enter the public realm and often go unchecked and repeated.

Abbott has a quality policy that we make our products as if they were for our own families. If quality were not our first priority Abbott would not still be here at 137 years. We dedicate ourselves every day to getting it right. That includes the people at Sturgis who have been villainized, followed and accosted.

It’s time to stop giving credence and fame to individuals with questionable agendas at the expense of alarming parents and taking advantage of their legitimate concern for their babies’ health and nutrition.

When these actions go unchecked, they have in the past led to unnecessary infant formula shortages, panic buying and public health scares that harm American families.

We feel we’ve responded to the allegations you’ve shared and demonstrated they are untrue, misleading or based on people without knowledge of our processes and who have questionable motivations.  

* Correction: The original post on April 4, 2025 in error stated “100 swabs per house” instead of the correct “10 swabs per house.”