The U.S. Food and Drug Administration is warning about products manufactured by Able Groupe that don't meet the agency's iron standards, among other requirements.

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Infant formula products, distributed beginning May 20 and manufactured by Able Groupe, are being recalled by the U.S. Food and Drug Administration (FDA). The products are sold under the brands HiPP, Holle, Bioland, and Kendamil.

The FDA announced on Monday that the products—which were imported from Europe and purchased by U.S. consumers online through the Little Bundle website—are being recalled for containing insufficient amounts of iron, especially for premature infants, those 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.

An image of baby formula.
Credit: Getty Images.

"Inadequate intake of iron during infancy may lead to iron deficiency anemia, which, if untreated, has irreversible cognitive and functional development outcomes," the FDA wrote in a press release on the recall.

The FDA requires infant formula products that contain less than one milligram of iron per 100 calories to display a statement on the label indicating that additional iron may be necessary. Eight of Able Group's products did not include the statement. And some products also failed to include mandatory labeling statements in English, as required by the Code of Federal Regulations.

They advise consumers who purchased the products to not use them as infant formula and to safely dispose of them immediately.

The recall will affect 76,000 units, which were first distributed starting on May 20.

The specific 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

If you purchased any of these products and have questions, the FDA recommends reaching out to recallquestions@ablegroup.com.