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Able Groupe has recalled some infant formula products because they did not meet US Food and Drug Administration requirements for iron content.
The company also didn’t submit pre-market notifications to the FDA before its products hit U.S. shelves, the agency said.
HiPP Comfort Infant Formula, HiPP Dutch Stage 1 Combiotic Infant Formula, HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Formula, HiPP German Stage 1 Combiotic Infant Formula, Holle Bio Stage 1 Bio Infant Formula, Holle Bio Stage PRE Bio Infant Milk Formula, Life Value Formula and HiPP UK Stage 1 Combiotic First Infant Milk Formula products contain less than 1 milligram of iron per 100 calories and may not provide enough iron for some infants, according to the FDA.
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According to the FDA, the products may have harmed infants born prematurely or with low birth weight, those with low iron levels at birth, or those at risk of iron deficiency due to illness.
Inadequate iron intake in infancy can lead to iron deficiency anemia, which, if left untreated, can lead to irreversible cognitive and functional developmental outcomes.
Eight Able Groupe baby food products did not have the required labels
According to the FDA, infant formula products that contain less than 1 milligram of iron per 100 calories must have a label on the label indicating that additional iron may be required.
Eight Able Groupe infant formula products did not have the required labels. The products of the Able Groupe were not only sold without labeling, but also without the mandatory nutritional labeling and not with the mandatory labeling information in English.
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The products were imported from Europe and distributed to US consumers by mail. US buyers may have purchased the products through www.littlebundle.com because the formulas were not available from any US retail store.
Able Groupe started selling the products on May 20, 2021 and around 76,000 units have been sold since then. The products that violate FDA standards will be recalled.
The FDA advises consumers who have these products at home not to use them as infant formula and to dispose of them immediately.
This story was told from Los Angeles.