Six months after a powdered baby formula recall shuttered its Michigan facility, Abbott is still working towards fully resuming production at the Sturgis factory.
The plant briefly reopened in June, but severe storms and flooding caused yet another shutdown until July 1, the company said in a statement.[1]
The Food and Drug Administration (FDA) is still working with Abbott and other suppliers to address the ongoing baby formula shortage.
How soon will the formula made at the Abbott facility be available again?
The Abbott facility in Michigan reopened on June 4 after meeting the FDA's multi-step guidelines. It then shuttered again on June 15 due to storm damage. Production of specialty EleCare formula finally restarted in July, and the factory will begin manufacturing Similac products again as soon as it can.
"Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step ... so we can ease the nationwide formula shortage," said Abbott Chairman and CEO Robert B. Ford in an earlier statement about the agreement with the FDA.[2]
In February, some Similac, Alimentum and EleCare powdered baby formula products were recalled after their potential link to serious illness in four infants across three states.
Before striking the deal with the FDA about the plan to restart production, Abbott had already begun reviewing training and safety procedures, upgrading the facility, and updating protocols related to water, cleaning and maintenance procedures at the factory, the company said.
In the meantime, a federal plan to boost supply includes importing more formula from overseas and ramping up domestic manufacturing using the Defense Production Act.
If you're formula-feeding your little one, here's what you need to know about the recall and how to keep your baby safe and fed.
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What infant formulas were recalled?
The recalled infant formulas were all produced at the Abbott Nutrition plant located in Sturgis, Michigan. They include some Similac, Alimentum and EleCare powdered baby formulas found across the United States and in other countries.
To check if any of your formula is included in the recall, look for the product code printed near the expiration date on the packaging.
Do not use the formula 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
Similac PM 60/40 with the lot code 27032K80 (on cans) and 27032K800 (on cases) is also now included in the recall. It's the only type and lot of this specialty formula affected.
If you own any products included in the recall, go to similacrecall.com for a refund or replacement. Avoid using the recalled formula and throw it out immediately. Talk to your pediatrician if you have any questions about finding alternative feeding options.
Liquid formula products aren't affected or included in the recall, and they're safe to use.
Why were these baby formulas recalled?
The FDA and the Centers for Disease Control and Prevention (CDC) investigated possible links between the Michigan-made formula and serious bacterial infections in babies. Four infants were hospitalized in three states — Minnesota, Ohio and Texas — and Cronobacter may have caused the illnesses in all four babies, two of whom later died.
According to an FDA report, Abbott Nutrition had previously found Cronobacter in its Sturgis, Michigan, plant on eight occasions between October 2019 and February 2022.[3] Multiple FDA samples collected in February also came back as testing positive for the bacteria.
What's more, federal inspectors noticed standing water in production areas, deteriorating machinery, employees not wearing necessary protective apparel, and other serious concerns during their visits.
However, in two available samples from the sick babies, the strains of the bacteria that may have caused their illnesses didn't match those found at the Abbott plant, nor did they match each other, according to Abbott.
What is Cronobacter?
Cronobacter sakazakii is a bacteria found in the natural environment. It can also live in dried foods like infant formula, powdered milk and herbal teas.
According to the CDC, Cronobacter infections are rare but potentially deadly in newborns.[4] They can lead to serious conditions like sepsis (a blood infection) and meningitis (swelling of the linings surrounding the brain and spinal cord).
Symptoms related to Cronobacter infections include:
- Fever
- Poor feeding
- Crying or irritability
- Very low energy
- Jaundice
- Grunting breaths
- Abnormal body movements
If your infant has these symptoms, take her to the doctor or the hospital right away. Your baby may receive antibiotics to fight the infection, as well as some tests to look for any potential complications.
You can report an illness or adverse event to the FDA online or over the phone.
How to keep your baby safe from foodborne illnesses
In addition to checking your formula and throwing away any products included in the recall, you can take the following steps to prevent Cronobacter infections and other foodborne illnesses in your baby:
- Consider using liquid infant formula. Feeding your baby liquid infant formula if you're able to is less likely to transmit bacteria like Cronobacter, according to the CDC.
- Clean and store baby feeding products safely. Prevent contamination by sterilizing baby bottles, breast pump parts if you use them, and other feeding items.
- Prepare powdered infant formula correctly. Never use expired formula, and keep lids, scoops and countertops clean. Always follow the manufacturer's instructions on how to dilute the formula, and feed it to your baby within two hours of preparation. Throw any leftovers away, or refrigerate them and use the refrigerated formula within 24 hours.
- Keep your hands clean. Always wash your hands with soap and water before preparing formula and feeding your baby.
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