Baby Formula Recall These Products Are Being Recalled Over Concerns Of Iron Insufficiency

The recall, announced on Monday, is for infant formula products that were sold under the brands: HiPP, Holle, Bioland and Kendamil.

The FDA said the formula contains insufficient amounts of iron, particularly for infants born prematurely or with a low birth weight, those who had low iron levels at birth or those who are at risk of being iron deficient due to illness.

While Kendamil is among the brands listed in the announcement, the company’s products do contain iron within the FDA’s required range. However, it is still under the agency’s recall.

If babies do not get enough iron, the FDA says infants could develop iron deficiency anemia, “which, if untreated, has irreversible cognitive and functional development outcomes.”

The FDA requires infant formula products that contain less than one milligram of iron per 100 calories to include a statement on the label indicating that additional iron may be necessary but eight of Able Group’s products did not.

Some products also failed to include mandatory labeling statements in English, as required by the Code of Federal Regulations.

The affected products were purchased through the Little Bundle website. The formulas were imported from Europe and mailed to consumers in the U.S. They were not sold in any retail store.

The FDA estimates that the recall will affect 76,000 units, which were distributed beginning May 20.

“Consumers who have these products at home should not use them as infant formula and should safely dispose of them immediately,” the FDA wrote in a press release.

The agency is helping coordinate the recall with Able Group. Customers with questions are being directed to email recallquestions@ablegroup.com.

The products being recalled are:

HiPP Anti-Reflux Milk FormulaHiPP Comfort Milk FormulaHiPP Dutch Stage 1 Combiotic Infant Milk FormulaHiPP Dutch Stage 2 Combiotic Follow-on Milk FormulaHiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk FormulaHiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk FormulaHiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-on Milk FormulaHiPP German Stage 1 Combiotic Infant Milk FormulaHiPP German Stage 2 Combiotic Follow-on Infant Milk FormulaHolle Bio Stage PRE Organic Infant Milk FormulaHolle Bio Stage 1 Organic Infant Milk FormulaHolle Bio Stage 2 Organic Follow-on Milk FormulaHolle Goat Stage 1 Organic Infant Milk FormulaHolle Goat Stage 2 Organic Follow-On Infant Milk FormulaHolle Goat Stage 3 Organic Toddler FormulaLebenswert Anfangsmilch Stage 1 Organic Infant Milk FormulaLebenswert Anfangsmilch Stage 2 Organic Follow-on Milk FormulaHiPP UK Stage 1 Combiotic First Infant Milk FormulaHiPP UK Stage 2 Combiotic Follow-on Infant Milk FormulaKendamil Organic Stage 1 First Infant Milk FormulaKendamil Organic Stage 2 Follow on Milk Formula

Correction (02/15/22 6:39 p.m.): An earlier version of this story did not specify that Kendamil’s products have the required amount of iron under U.S. regulations.