Abbott Nutrition & FDA Reopen Facility Involved in Formula Recall Amid Shortage
Six months after a powdered baby formula recall shut down its Michigan facility, Abbott is still working toward fully resuming production at the Sturgis factory.
The plant briefly reopened in June, but severe storms and flooding caused another shutdown until July 1, the 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 shortage of infant formula.
How soon will formula produced at the Abbott facility be available again?
Abbott’s Michigan facility reopened on June 4 after meeting FDA guidelines in several steps. It closed again on June 15 due to storm damage. Production of EleCare’s specialty formula resumed in July, and the factory will resume production of Similac products soon.
“Our number one priority is getting babies and families the high-quality formula they need, and this is a major step … so we can alleviate formula shortages across the country,” 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 babies in three states.
Before striking a deal with the FDA over the plan to restart production, Abbott began reviewing training and safety procedures, upgrading facilities, and updating water-related protocols, cleaning and maintenance procedures at the factory, the company said.
In the meantime, a federal plan to boost supply includes importing more formulas from abroad and ramping up domestic manufacturing using the Defense Production Act.
If you’re formula feeding your child, here’s what you need to know about the recall and how to keep your baby safe and fed.
What baby formulas have been recalled?
The remembered the baby formulas all manufactured at the Abbott Nutrition plant located in Sturgis, Michigan. These include some Similac, Alimentum and EleCare powdered baby formulas found throughout the United States and in other countries.
To check if any of your formulas are 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 to 37 and
- The code on the container contains K8, SH, or Z2, and
- Expiration date is 4-1-2022 (APR 2022) or later
The recall also includes Similac PM 60/40 with lot code 27032K80 (in cans) and 27032K800 (in cases). This is the only type and many are affected by this specialty formula.
If you own any products included in the recall, go to similarcall.com for refund or replacement. Avoid using the recalled formula and discard it immediately. Talk to your pediatrician if you have any questions about finding alternative feeding options.
Liquid formula products are not affected or included in the recall, and they are 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 infants. Four babies were hospitalized in three states – Minnesota, Ohio and Texas – and Cronobacter may have caused illnesses in all four babies, two of whom later died.
According to a FDA reportPreviously found by Abbott Nutrition Cronobacter at its plant in Sturgis, Michigan, on eight occasions between October 2019 and February 2022.[3] Multiple FDA samples collected in February also came back testing positive for the bacteria.
Furthermore, federal inspectors noted standing water in production areas, deteriorating machinery, employees not wearing required protective clothing, and other serious concerns during their visits.
However, in the two available samples from the sick babies, the strains of bacteria that may have caused their illnesses did not match those found at the Abbott plant, nor did they match each other, according to to Abbott.
What is Cronobacter?
Cronobacter sakazakii is a bacteria found in the natural environment. It can also survive in dried foods such as baby formula, milk powder and herbal teas.
According to the CDC, Cronobacter infections is rare but can be fatal in newborns.[4] They can lead to serious conditions such as sepsis (a blood infection) and meningitis (inflammation of the linings surrounding the brain and spinal cord).
Symptoms associated with Cronobacter infections include:
- Fever
- Poor feeding
- Crying or upset
- Very low energy
- Jaundice of the skin
- Grunts of breath
- Abnormal body movements
If your baby has these symptoms, take him 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 o on the phone.
How to keep your baby safe from foodborne illnesses
In addition to checking your formula and disposing of any product included in the recall, you can take the following steps to avoid Cronobacter infections and other foodborne illnesses in your baby:
- Consider using liquid infant formula. Feeding your baby liquid infant formula if you can is less likely to carry bacteria such as 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. Do not 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 away any leftovers, 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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