The following provides current information on the findings from the investigation, our Sturgis, Mich., facility and supply.
The February voluntary recall involved four complaints of Cronobacter sakazakii — a common environmental bacteria — in infants who consumed infant formulas produced in this plant. Two infants became sick; two tragically passed away.
The facts about what was learned about the cases of Cronobacter have not been widely communicated. After a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses.
It’s important to know:
- Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella.
- All finished product testing by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter and/or Salmonella. No Salmonella was found at the Sturgis facility.
- The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of the facility and has not been linked to any known infant illness. Specifically:
- Genetic sequencing on the two available samples from ill infants did not match strains of Cronobacter in our plant. Samples from ill infants did not match each other, meaning there was no connection between the two cases.
- In all four cases, the state, FDA, and/or CDC tested samples of the Abbott formula that was used by the child. In all four cases, all unopened containers tested negative.
- Open containers from the homes of the infants were also tested in three of the four cases; two of the three 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, one of which 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. Again, neither strain matched strains found in our plant.
- The infants consumed four different types of our formula made over the course of nearly a year and the illnesses took place over several months in three different states.
Regarding the status of our work to reopen Sturgis:
The FDA concluded its inspection with a 483 letter to Abbott on March 18. This is a list of observations that point out where Abbott did not follow our processes and where we can improve our systems and protocols.
We take this very seriously and we responded to the 483 on April 8. Even before our formal response, we had begun working to address these issues, implement improvements and take corrective action. Some of these actions have included reviewing and updating education, training and safety procedures for both employees and visitors, as well as updating our protocols regarding water and cleaning and maintenance procedures at the facility. We immediately implemented corrections to address the items the FDA raised in the 483. We’ve also been making upgrades to the plant, including installing nonporous, easily cleanable and sanitary floors.
We know the recall has worsened an already existing industry-wide infant formula shortage in the U.S. and we’ve been seeing and hearing the stress and despair of parents who are facing empty shelves. We deeply regret the situation and since the recall, we’ve been working to increase supply at our other FDA-registered facilities, including bringing in Similac from our site in Cootehill, Ireland, by air and producing more liquid Similac and Alimentum. We also began releasing metabolic formulas that were on hold earlier this month at FDA’s request to those who need these unique formulas.
We understand the situation is urgent – getting Sturgis up and running will help alleviate this shortage. Subject to FDA approval, we could restart the site within two weeks. We would begin production of EleCare, Alimentum and metabolic formulas first and then begin production of Similac and other formulas. From the time we restart the site, it will take six to eight weeks before product is available on shelves.
Our Efforts to Address Infant Formula Supply
Millions of parents rely on our formula to feed their babies. And we know that our recent recall caused additional stress and anxiety in an already challenging situation of a global supply shortage. We are working hard to help moms, dads and caregivers get the high-quality nutrition they need for their babies.
Abbott is working closely with the U.S. Food and Drug Administration (FDA) to restart operations at the Sturgis, Mich., facility. We continue to make progress on corrective actions and will be implementing additional actions as we work toward addressing items related to the recent recall. In the meantime, we are working to increase the supply of infant formula by prioritizing infant formula production at our facilities that provide product to the U.S. market.
Shipping Formula From Cootehill, Ireland
We have an FDA-registered plant in Cootehill, Ireland, where we’ve increased the volume of Similac Advance powder formula produced for the U.S. We’re air-shipping product from this facility into the U.S. daily and the product is being restocked regularly.
Our Cootehill team sources ingredients from approximately 1,000 dairy farms in the local area. Following stringent quality and safety processes, each batch of infant formula undergoes extensive quality checks before it reaches stores.
Prioritizing Infant Formula Production in Columbus, Ohio
Columbus, Ohio, is the headquarters for Abbott’s U.S. nutrition business and is home to one of our five manufacturing facilities that produce infant formula for the U.S. market. At this facility we’ve made significant changes to ensure we can prioritize production of Similac Ready-to-Feed liquid formula, a product that can be used directly from the bottle. In the second quarter of the year, we expect to produce nearly three times more Similac Ready-to-Feed liquid formula than we did during the same period of time last year. And this product will be available on retail shelves and online soon.
Across the U.S., we’re prioritizing production of infant formula products to help replenish the supply in the market. And, this year, we will more than double the amount of Similac Advance powder formula we’re bringing in from our manufacturing facility in Cootehill, Ireland.
We are dedicated to doing everything possible to ensure parents and caregivers have what they need to feed their babies. And we’re always focused on what we can do to continue to serve our customers. We will continue to work closely with the FDA to implement corrective actions at the Michigan facility.
We know getting your baby high-quality infant formula is your priority — it is ours too.
March 22, 2022
Abbott Update On Powder Formula Recall
We are currently reviewing the FDA’s observations as provided in its Form 483 from its inspection of our powder formula manufacturing in our Sturgis, Mich., facility. We’re taking this very seriously and are working closely with the FDA to implement corrective actions.
While there are actions we need to take to address the FDA observations, it is important to note that no Cronobacter sakazakii or Salmonella was found in any of our testing of products distributed to consumers. Additionally, the unique genetic makeup of the Cronobacter sakazakii microbes found in non-product contact areas at the Sturgis facility did not match the Cronobacter sakazakii microbes from the reported cases. This follows the FDA’s removal of the Salmonella case from its investigation earlier this month.
Our Commitment to Industry-leading Quality and Safety
Abbott is committed to upholding the highest standards for manufacturing of all nut…