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Powder milk and blue spoon on light background close-up.
(Photo Credit: Dragana Gordic/Shutterstock)

FDA Abbott Similac Alimentum EleCare Chronobacter Baby Formula Recall Overview:

  • Who: The U.S. Food & Drug Administration says it is working to increase the availability of certain specialty infant formula products after a massive recall of Abbott powdered formulas.
  • Why: The Abbott recall exacerbated a shortage of specialty baby formulas.
  • Where: The recall and formula shortage and United States.

The U.S. Food & Drug Administration (FDA) says it is working to increase the availability of certain infant formula products after a massive recall of Abbott powdered formulas left some parents scrambling to find specialty and metabolic formulas that their babies need.

On Feb. 17, the agency warned consumers not to use certain Similac, Alimentum and EleCare powdered infant formula products from Abbott Nutrition’s Sturgis, Michigan, facility after it was linked to a rash of infant illnesses and potentially two infant deaths. 

Abbott initiated a recall of certain products soon after, and the recall was later expanded to include Similac PM 60/40. 

Since then, the agency has been working with Abbott and other manufacturers to bring safe products to the U.S. market, it said in a May 10 press release updating the public. 

“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so,” FDA Commissioner Robert M. Califf says in the press release. “We are doing everything in our power to ensure there is adequate product available where and when they need it.” 

FDA ‘Working Tirelessly” To Address, Alleviate Infant Formula Supply Issues

The FDA said it had been “working tirelessly” to address and alleviate supply issues for speciality formulas, which have been exacerbated by the pandemic. 

It added that other infant formula manufacturers had been meeting or exceeding capacity levels to meet current demand. 

“Notably, more infant formula was purchased in the month of April than in the month prior to the recall,” the press release says.

The FDA says it is meeting regularly with major infant formula manufacturers to better understand their capacity to increase production of various types of infant formulas and medical foods. 

“Efforts already underway by several infant formula manufacturers include optimizing processes and production schedules to increase product output, as well as prioritizing product lines that are of greatest need, particularly the specialty formulas,” according to the press release.

The FDA says it is helping those processes by streamlining the process to bring products to market. 

Abbott Did Not Maintain Sanitation at Plant, FDA Says

The FDA also said it does not object to Abbott Nutrition releasing product to individuals needing urgent, life-sustaining supplies of certain specialty and metabolic formulas on a case-by-case basis. 

The agency continues to advise against making infant formulas at home.

So far in its investigation, the FDA has concluded that Abbott Nutrition did not maintain sanitary conditions at the Michigan manufacturing plant where it produced baby formula linked to the infant illnesses.

Several parents whose babies drank the recently recalled infant formula are suing the company over the contaminated product.

Meanwhile, U.S. senators are demanding Abbott Nutrition hand over documents related to its recall after it was revealed the company may have known about contamination since September last year.

If your child became sick after consuming the recalled baby formula, you may be able to join a class action lawsuit investigation and obtain compensation. Click here for more information (links to paid attorney content).


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One thought on FDA Works To Increase Availability of Baby, Specialty Formulas Amid Abbott Investigation

  1. BARBARA L ROGERS says:

    please add me

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