A recall order has been issued AMB Group Some products are used as infant formula milk powder because they contain insufficient iron and meet the requirements of the Food and Drug Administration.
The recalled infant formula was imported from Europe and distributed to consumers in the U.S. through the website and mail service www.littlebundle.com. These products are not available in any retail stores.
According to the recall notice, Able Groupe began shipping the affected formula milk on May 20. Approximately 76,000 units were distributed.
The recalled infant formula products are intended to completely or partially replace breast milk for children 12 months and younger. However, according to the FDA, these new infant formulas have not been submitted to the agency for the necessary pre-market notifications.
This formula contains less than 1 mg of iron per 100 calories, and may not provide enough iron for some babies, including babies born prematurely, with low birth weight, or low iron content. Insufficient iron levels can lead to iron deficiency anemia, which can lead to irreversible cognitive and functional development.
According to FDA regulations, infant formula with less than 1 mg of iron per 100 calories must indicate on the label that additional iron supplements may be required. The labels of these recalled formulas did not contain a statement.
The recalled products include:
- HiPP comfort milk formula
- HiPP Netherlands Phase I Compound Infant Formula Milk Powder
- HiPP HA German Hypoallergenic Stage PRE Combination Infant Formula Milk Powder
- HiPP German Phase I Compound Infant Formula Milk Powder
- Holle Bio Stage 1 Organic Infant Formula Milk Powder
- Holle Bio Stage PRE Organic Infant Formula Milk Powder
- Lebenswert Stage 1 Organic Infant Formula Milk Powder
- HiPP UK Stage 1 Combiotic First Infant Milk Formula
A full list of affected products and labels can be viewed here.
Consumers with recalled infant formula should not use the product. The formula should be processed.
Questions about the recall can be emailed to Recall issues@ablegroupe.com.
The agency stated that all infant formulas distributed by Able Groupe are not marked in accordance with FDA requirements. Therefore, the company recalled all batch codes.
Photo: Reuters
