Update from June 15, 2022
The following statement was posted by Abbott regarding its Sturgis plant and formula production:
Severe thunderstorms and heavy rains came through southwestern Michigan on Monday evening, resulting in high winds, hail, power outages and flood damage throughout the area. These torrential storms produced significant rainfall in a short period of time – overwhelming the city’s stormwater system in Sturgis, Mich., and resulting in flooding in parts of the city, including areas of our plant.
As a result, Abbott has stopped production of its EleCare specialty formula that was underway to assess damage caused by the storm and clean and re-sanitize the plant. We have informed FDA and will conduct comprehensive testing in conjunction with the independent third party to ensure the plant is safe to resume production. This will likely delay production and distribution of new product for a few weeks.
Based upon historical demand and current projections, Abbott has ample existing supply of EleCare and most of its specialty and metabolic formulas to meet needs for these products until new product is available. These products are being released to consumers in need in coordination with healthcare professionals. Parents or caregivers in need should contact their healthcare professional or contact Abbott at +1-800-881-0876 for additional information.
Abbott will have produced 8.7 million pounds of infant formula in June for the U.S., or the equivalent of 168.2 million 6 oz. feedings. This is 95% of what we produced in January, prior to the recall and does not include production from Sturgis.
Once the plant is re-sanitized and production resumes, we will again begin EleCare production, followed by specialty and metabolic formulas. In parallel, we will work to restart Similac production at the plant as soon as possible.
Update from May 25, 2022
Abbott has shared a press release with more information about the release of limited amounts of EleCare amino acid-based formulas to help meet critical patient need during the formula shortage.
Abbott has also provided the attached letter and urgent medical need form that may be shared with health care professionals with instructions and more information about how to order EleCare or EleCare Jr Vanilla for patients with urgent medical needs.
Updates from May 13, 2022
Abbott has released two statements this week regarding formula supply and the priority work being done to mitigate the supply issue after the company initiated a voluntary recall after complaints of Cronobacter sakazakii — a common environmental bacteria — in infants who consumed infant formulas produced in their Sturgis, Mich. facility.
We are including the full statements below, which can also be found on Abbott’s website.
May 13, 2022 Abbott Statement
Since the recall, one of our priorities has been to mitigate the supply issues. In particular we’ve been focusing on production in our Cootehill, Ireland, facility to serve state Special Supplemental Nutrition Program for Women, Infants and Children (WIC) consumers. Abbott has been working with the USDA and WIC agencies and paying rebates on competitive products in states where Abbott holds the WIC contract, when Similac is not available. Abbott will continue to pay rebates for competitive products through August 31. This means program participants will continue to be able to obtain formula, free of charge whether it is Similac or formula from another manufacturer.
We know that the recall has worsened the industry-wide infant formula shortage, and we have been working to get as much product into the hands of parents as we can. Since February:
We’ve air shipped millions of cans of infant formula powder into the U.S. from our FDA-registered facility in Cootehill, Ireland.
We have prioritized infant formula production at our Columbus, Ohio, facility, converting other liquid manufacturing lines into manufacturing Similac liquid ready-to-feed.
We are offering an increased number and value of coupons available for all our infant formula products, including Similac ready-to-feed, to enable customers to purchase formula, either free or deeply discounted.
And our other manufacturing facilities are running at full capacity as we continue to prioritize production of infant formula to help replenish the supply in the market.
At the same time, we have been working to address the FDA’s 483 observations so we can restart operations at the Sturgis, Mich., facility. We immediately began implementing corrective actions and subject to FDA approval, we could restart our Sturgis, Mich., site within two weeks.
We are confident that we can continue to produce safe, high-quality infant formula at all of our facilities as we have been doing for millions of babies around the world for decades.
May 11, 2022 Abbott Statement
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.
The current formula shortage is a significant crisis, and we expect resolution in the near future.
For those who are denied reimbursement by insurance for elemental formula, the lack of access will continue until there is legislation to facilitate that access.
Please join APFED as we call on Congress to resolve this issue through enactment of the Medical Nutrition Equity Act. Visit nutritionequity.org to learn more and to take action!
More Resources and Prior Updates
Important Alert for Community Members Who Use Similac®, Alimentum®, or Elecare® Powdered Formula
The U.S. Food and Drug Administration (FDA) is investigating consumer complaints of Cronobacter and Salmonella infections. All cases reportedly consumed powdered infant formula produced from the Abbott Nutrition facility in Sturgis, Michigan. Abbott has issued a voluntary recall of powdered formulas manufactured in Sturgis. Products made in this facility can be found throughout the U.S.
The FDA is advising consumers not to use Similac, Alimentum, or EleCare powdered infant formulas if:
• 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.
This investigation is related to four illnesses (three for Cronobacter and one for Salmonella) in the following states: Minnesota, Ohio, and Texas. All four cases related to these complaints were hospitalized, and in one case Cronobacter may have contributed to a death.
On 2/28, Abbott announced it was also voluntarily recalling one lot of Similac PM 60/40 (Lot # 27032K80 (can) / Lot # 27032K800 (case))
In a statement published by Abbott, the company shares, “Additionally, as part of Abbott’s quality processes, we conduct routine testing for Cronobacter sakazakii and other pathogens in our manufacturing facilities. During testing in our Sturgis, Michigan, facility, we found evidence of Cronobacter sakazakii in the plant in non-product contact areas. We found no evidence of Salmonella Newport. This investigation is ongoing….Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. All finished infant formula powder products are tested for Cronobacter, Salmonella, and other pathogens, and they must test negative before the product is released. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter. And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella. While Abbott’s testing of distributed product detected no pathogens, we are taking action by recalling the powder formula manufactured in this facility with an expiration of April 1, 2022, or later. No Abbott liquid formulas are included in the recall, nor are powder formulas or nutrition products from other facilities.”
If you or your child are impacted by this recall, please speak to your health care provider about interim alternative options for elemental formula that may be appropriate for you, such as Essential Care, EquaCare, PurAmino and Neocate.
Full FDA announcement.
SimilacRecall.com: This website is dedicated to this recall so that parents can get information, determine if the product they have is included in the recall using the lot locator, and learn how to secure a refund or replacement product.
Consumer Relations Hotline:
Abbott has a Consumer Relations hotline (1-800-986-8540) to ensure parents get their questions answered, determine if any of the product they have is included in the recall and get the most up-to-date information.
Video on Similac.com from Abbott’s Pediatric Medical Director and Pediatrician, Dr. Karyn Wulf that speaks directly to parents to provide them with more information about what led to the recall. Sharing this with parents is also a helpful way to provide them with the most up-to-date information available.
Video on EleCare.com from Abbott’s Pediatric Medical Director and Pediatrician, Dr. Karyn Wulf, sharing with parents whose babies and/or children who rely on Alimentum or EleCare.
What You Can Do
- Check to see if the formula you have is affected by the recall, by checking the lot number on the Abbott website.
- Do not dilute formula, such as by adding water, in attempt to make your existing supply last, nor attempt to make your own formula.
- Speak to your doctor before making any changes to your diet or before using an alternate formula (see below).
Elemental Formulas Not Affected by the Recall
- Cambrooke manufacturers EquaCare and Essential Care elemental formulas. They shared with us on March 23 that their unflavored and vanilla flavors are shipping within 10 business days. For Chocolate, White Chocolate and Citrus are taking a little longer to ship.
- Neocate’s blog post describes how they are addressing product demand, and they released this update.
- Puramino can be ordered online has a zipcode locator to assist parents in finding the product locally. It may also be purchased through Amazon, Their customer number is 1-800-BABY-123 to assist parents with questions.
How We are Advocating
APFED is sharing information with patients, caregivers, clinicians and researchers, and to formula manufacturers. We are working collaboratively with research partners and other advocates to capture data related to accessing specialty ingredients and medical foods like formula during supply chain disruptions, and impacts on health and disease management. The outputs from these collaborations will be published and disseminated to help inform future policies and frameworks to facilitate access to medical foods during events such as supply chain disruptions. We’ll continue to keep you posted.