HiPP Infant formula is recalled for insufficient iron content and mislabeling. In addition, the company Able Groupe, did not submit required pre-market notifications for these new formulas to the FDA as required by law. These formulas are products that are intended to be complete or partial substitutes for human milk for children 12 months old and younger.
The recalled products 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, and HiPP UK Stage 1 Combiotic First Infant Milk Formula, among others. All lot codes are recalled. You can see the age recommendation for these products, as well as the iron content in milligrams per 100 calories, in a chart on the FDA web site. You can also see pictures of product labels there.
These products were imported from Europe and distributed to customers in the U.S. via mail order, through purchase at the littlebundle website. The items were not available in any retail stores. The company started distributing these products on May 20, 2021. About 76,000 units were sold.
The formulas have less than 1 milligram of iron per 100 calories, which is required by the FDA unless a statement on the label tells consumers that more iron intake may be necessary for their children. And the formulas distributed by Able Groupe are not labeled with mandatory statements in English.
Inadequate intake of iron during infancy may lead to iron deficiency anemia, which, if not treated, has irreversible cognitive and functional development outcomes. Premature infants and babies born with a low birth weight, or who are at risk for becoming iron deficient due to illness, are especially vulnerable.
If you purchased these items, do not use them as infant formula. Throw them away immediately in a double sealed package in a secure trash can.
