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

The U.S. Food and Drug Administration announced that some baby formula products manufactured by Able Groupe are being recalled for not meeting the agency's iron standards, among other requirements.

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.

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.

Baby Formula Infant Recall FDA
The FDA is recalling baby formula products for not containing enough iron. A mother feeds her 10-week son on June 17, 2020 in Stamford, Connecticut. John Moore/Getty

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 Formula
  • HiPP Comfort Milk Formula
  • HiPP Dutch Stage 1 Combiotic Infant Milk Formula
  • HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula
  • HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula
  • HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula
  • HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-on Milk Formula
  • HiPP German Stage 1 Combiotic Infant Milk Formula
  • HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula
  • Holle Bio Stage PRE Organic Infant Milk Formula
  • Holle Bio Stage 1 Organic Infant Milk Formula
  • Holle Bio Stage 2 Organic Follow-on Milk Formula
  • Holle Goat Stage 1 Organic Infant Milk Formula
  • Holle Goat Stage 2 Organic Follow-On Infant Milk Formula
  • Holle Goat Stage 3 Organic Toddler Formula
  • Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula
  • Lebenswert Anfangsmilch Stage 2 Organic Follow-on Milk Formula
  • HiPP UK Stage 1 Combiotic First Infant Milk Formula
  • HiPP UK Stage 2 Combiotic Follow-on Infant Milk Formula
  • Kendamil Organic Stage 1 First Infant Milk Formula
  • Kendamil Organic Stage 2 Follow on Milk Formula