WASHINGTON, D.C. – According to an online news report on ibtimes.com.au, Able Groupe has issued a recall for several of the company’s infant formula products. The U.S. Food & Drug Administration issued an alert that Able Groupe has issued a recall of many baby formula products due to “an insufficient amount of iron as required by the Food and Drug Administration.” The affected baby formula products were imported from Europe and then distributed to U.S. consumers via the company’s website www.littlebundle.com. The infant formula products were not made available at retail stores.
Able Groupe started shipping the recalled formula on May 20, 2021. It is estimated that approximately 76,000 units were distributed inside the United States. The infant formula products are designed to provide infants with a complete or partial substitute for human milk. The formula is also made for infants who are 12 months old and younger. However, the FDA stated that the new infant formulas were not submitted for the required pre-market notifications as required by the FDA.
The baby formula products were found to have less than 1 mg of iron per 100 calories, and it does not meet the minimum daily amount of iron needed for infant development. The issue is particularly an issue for premature babies who have low iron levels or low birth weight. Babies deficient in iron can develop iron-deficiency anemia leading to irreversible functional and cognitive development outcomes.
The FDA states that any infant formula with less than 1 mg of iron per 100 calories is legally required to provide a statement on the label indicating that additional iron may be necessary. A statement was not included on the label of these recalled formulas.
The affected milk products include:
- HiPP UK Stage 1 Combiotic First Infant Milk Formula
- HiPP Comfort Milk Formula
- HiPP Dutch Stage 1 Combiotic Infant Milk Formula
- HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula
- HiPP German Stage 1 Combiotic Infant Milk Formula
- Holle Bio Stage PRE Organic Infant Milk Formula
- Holle Bio Stage 1 Organic Infant Milk Formula
- Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula
A complete list of the affected baby formula products and labels can be viewed here. Consumers are being asked not to use any of the affected baby formulae and to throw the formula in the trash. The news report also states that all Able Groupe infant formula did not meet the labeling requirements of the FDA.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
Were you or a loved one harmed by a dangerous product? Parker Waichman LLP helps families recover monetary compensation for harm caused by dangerous products. For your free consultation, contact our law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
New York | Brooklyn | Queens | Long Island | New Jersey | Florida
Call us at: 1-800-YOURLAWYER (800-968-7529) | Schedule your free consultation