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European baby formula
(Photo Credit: Djordje Novakov/Shutterstock)

European Baby Formula Recall Overview: 

  • Who: Able Groupe, the Europe-based maker of HiPP, Holle, Bioland, and Kendamil-brand infant formula.  
  • Why: The company issued a recall of the European baby formula after US regulators discovered that the products failed to meet nutrition and labeling requirements.
  • Where: The recalled European baby formula was sold online to US customers nationwide.

HiPP, Holle, and other brands of European baby formula have been recalled for containing insufficient iron under American standards, according to a notice issued early this week.  

In addition to failing to meet US nutrition standards, the manufacturer, Able Groupe, has not yet submitted the products for review by the Food and Drug Administration (FDA), warned the agency’s recall notice.  

The recalled European baby formula products “contain less than 1 milligram of iron per 100 Calories and may not provide adequate iron for some infants, particularly infants born prematurely or with a low birth weight, those who had low iron levels at birth, or those who are at risk for becoming iron deficient due to illness,” says the FDA.  

“Inadequate intake of iron during infancy may lead to iron deficiency anemia, which, if untreated, has irreversible cognitive and functional development outcomes.” 

Recalled European baby formula products sold online 

The baby formula products that do not meet FDA requirements include: 

  • HiPP Comfort Milk Formula 
  • HiPP Dutch Stage 1 Combiotic Infant Milk Formula 
  • HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula 
  • HiPP German Stage 1 Combiotic Infant Milk Formula 
  • Holle Bio Stage 1 Organic Infant Milk Formula 
  • Holle Bio Stage PRE Organic Infant Milk Formula 
  • Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula 
  • HiPP UK Stage 1 Combiotic First Infant Milk Formula 

More than 76,000 units were sold to US consumers through the littlebundle website, says the FDA recall notice.  

Consumers are instructed to not use the recalled European baby formula and contact Able Groupe with questions.  

Infant formulas encompass products intended as a substitute for human milk for children who are less than 12 months old. They are subject to additional FDA nutritional and labeling requirements.  

Did you purchase HiPP, Holle, or other recalled European baby formula? Tell us about your experience in the comment section below.


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16 thoughts onRecall Check: European baby formula HiPP, Holle do not meet FDA requirements

  1. Cindy Miller says:

    Please add me.

  2. Terri says:

    Please add me.

  3. Kristen Fraker says:

    Please include… I have been giving my baby holle since she switched to formula

  4. Alina Gawronski says:

    I purchased Holle Bio Stage 1 and Lebenswert Anfangsmilch Stage 2 in April 2021. After feeding my small, premature baby during May and June, she became extremely underweight. I took her to the doctor and we couldn’t figure out what was wrong. The doctor even contacted Children Services because he thought maybe I was the one doing something wrong. After I stopped these products, my baby began gaining weight again by drinking Enfamil. So not only did I lose money because of Little Bundle and the Able Groupe, but I got investigated by Children Protective Services!
    Please include me in any and all lawsuits! I am happy to testify!.

  5. Melissa says:

    My baby was not doing well on this and then we found your website. We spent a lot on the formula but are stopping it immediately.
    please help us.

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