Best selling European Infant Formula products recalled because of insufficient iron levels
The recalled products are infant formulas (i.e., products intended as a complete or partial substitute for human milk for children 12 months old and younger), but the required pre-market notifications for these new infant formulas have not been submitted to the FDA.
The products were imported from Europe and distributed to consumers in the U.S. via mail services. All lots codes are being recalled.
This products contain less than 1 milligram of iron per 100 Calories and may not provide adequate iron for some infants, particularly infants born prematurely or with a low birth weight, those who had low iron levels at birth, or those who are at risk for becoming iron deficient due to illness.
Insufficient intake of iron during infancy may lead to iron deficiency anemia, which, if untreated, has irreversible cognitive and functional development outcomes.
The company identified the products as follows: (iron levels provided after each product name, milligrams per 100 Calories)
| 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 |
The recall is being coordinated with the U.S. Food and Drug Administration.
Consumers of the product who have questions can email them to: recallquestions@ablegroupe.com and do talk to your doctor about this issue.
For more information visit: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/able-groupe-recalling-products-labeled-infant-formula-formulas-have-insufficient-iron-levels