A long list of European import formulas distributed by a company called Able Groupe (no link, can only find a maintenance company) through the website littlebundle were recalled on August 8, 2021. As we have previously discussed, the FDA requires that before an infant formula is brought to market in the US, that companies register with the FDA and demonstrate that they meet the requirements for infant formula.
These formulas “are not labeled as required by 21 CFR 107.10 and 107.20 and do not bear mandatory labeling statements in English.”
Insufficient Iron
Eight of the formulas on the list also do not meet iron labeling requirements. Though the FDA requires 0.15–3 mg iron per 100 calories, manufacturers have to include a warning if there is less than 1 mg iron per 100 calories. This is because low iron intake can lead to iron deficiency anemia, which is associated with poor growth and neurodevelopmental outcomes.
One of the following statements shall appear on the principal display panel, as appropriate:
(i) The statement “Infant Formula With Iron”, or a similar statement, if the product contains 1 milligram or more of iron in a quantity of product that supplies 100 kilocalories when prepared in accordance with label directions for infant consumption.
(ii) The statement “Additional Iron May Be Necessary”, or a similar statement, if the product contains less than 1 milligram of iron in a quantity of product that supplies 100 kilocalories when prepared in accordance with label directions for infant consumption.
21 CFR 107.10(b)(4)(i)
These formulas do not contain 1 mg per 100 calories iron:
- 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 1 Organic Infant Milk Formula
- Holle Bio Stage PRE Organic Infant Milk Formula
- Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula
- HiPP UK Stage 1 Combiotic First Infant Milk Formula
This is the full list of recalled formulas:
| Product | Age | Iron mg per 100 Calories |
| HiPP Anti-Reflux Milk Formula | From birth | 1.06 |
| HiPP Comfort Milk Formula | From birth | 0.91 |
| HiPP Dutch Stage 1 Combiotic Infant Milk Formula | 0-6 months | 0.76 |
| HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula | 6+ months | 1.47 |
| HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula | 0-6 months | 0.76 |
| HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula | 6+ months | 1.01 |
| HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-on Milk Formula | 6+ months | 1.43 |
| HiPP German Stage 1 Combiotic Infant Milk Formula | 0-6 months | 0.90 |
| HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula | 6+ months | 1.47 |
| Holle Bio Stage PRE Organic Infant Milk Formula | 0-6 months | 0.81 |
| Holle Bio Stage 1 Organic Infant Milk Formula | 0-6 months | 0.81 |
| Holle Bio Stage 2 Organic Follow-on Milk Formula | 6+ months | 1.18 |
| Holle Goat Stage 1 Organic Infant Milk Formula | 0-6 months | 0.99 |
| Holle Goat Stage 2 Organic Follow-On Infant Milk Formula | 6+ months | 1.47 |
| Holle Goat Stage 3 Organic Toddler Formula | 10+ months | 1.52 |
| Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula | 0-6 months | 0.88 |
| Lebenswert Anfangsmilch Stage 2 Organic Follow-on Milk Formula | 6+ months | 1.43 |
| HiPP UK Stage 1 Combiotic First Infant Milk Formula | 0-6 months | 0.76 |
| HiPP UK Stage 2 Combiotic Follow-on Infant Milk Formula | 6+ months | 1.47 |
| Kendamil Organic Stage 1 First Infant Milk Formula | From birth | 1.10 |
| Kendamil Organic Stage 2 Follow on Milk Formula | 6+ months | 1.06 |
What to do?
Talk to your pediatrician. It may be possible to give supplemental iron to meet the nutritional needs of your baby. All babies should be screened for anemia (and lead!) at 12 months (or earlier if indicated).
Formulas labeled as “infant formulas” sold in stores in the US should meet FDA requirements. This does not include toddler formulas, which are entirely unregulated.
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