Public Alert No: 0035/2021 – Recall Of Products Labelled As Infant Formulas By Able Groupe Due To Insufficient Iron Levels And Failure To Meet Fda Requirements
September 27, 2021,
The National Agency for Food and Drug Administration and Control (NAFDAC) has received information from US FDA on the recall of certain infant Formulas manufactured by Able Groupe due to insufficient Iron levels and not meeting other FDA requirements. The recalled products were sold under the brand names HiPP, Holle, Bioland and Kendamil. The required pre-market notifications for these new infant formulas have not been submitted to the FDA.
Able Grope’s products including 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 1 Organic Infant Milk Formula, Holle Bio Stage PRE Organic Infant Milk Formula, Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula, and HiPP UK Stage 1 Combiotic First Infant Milk Formula products contain less than 1 milligram of iron per 100 Calories These eight (8) infant formula product labels listed above cdo not include the required statement. Furthermore, all of the infant formulas distributed by Able Group are not labeled as required by Code of Federal Regulations Title 21 (21 CFR 107.10 and 107.20).
The recalled products are infant formulas which are products intended as a complete or partial substitute for human milk for children of 12 months old and younger. Infant milk formulas containing less than 1 milligram (1mg) of Iron per 100 Calories 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. Inadequate intake of iron during infancy may lead to iron deficiency anemia, which, if untreated, has irreversible cognitive and functional development outcomes. Infant formula products that contain less than 1 milligram of iron per 100 Calories are required to include a statement on the label indicating that additional iron may be necessary.
The details of the recalled infant formulas are shown in the table below:
|Product||Age||mg of iron per 100 calories|
|HiPP anti-reflux milk formula||Since birth||1.06|
|HiPP comfort milk formula||Since birth||0.91|
|HiPP Dutch Stage 1 Combiotic Infant Milk||0-6
|HiPP Dutch Stage 2 combiotic follow-on milk||6+ months||1.47|
|HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula||0-6
|HiPP HA Germany Stage 1 Hypoallergenic Combiotic Infant Formula||6+ months||1.01|
|HiPP HA Germany Stage 2 Hypoallergenic Combiotic Follow-Up Milk||6+ months||1.43|
|German HiPP Stage 1 Combiotic Infant Milk||0-6
|Lebenswert Anfangsmilch Stage 1 organic Infant milk||0-6
|HiPP German Stage 2 Combiotic Follow-on Milk for Infants||6+ months||1.47|
|Holle Bio Stage PRE organic infant milk formula||0-6
|Holle Bio Stage 1 organic infant milk formula||0-6
|Holle Bio Stage 2 organic follow-on milk formula||6+ months||1.18|
|Holle Goat Stage 1 organic infant formula||0-6
|Holle Goat Stage 2 Organic Infant Follow-on Milk||6+ months||1.47|
|Holle Goat Stage 3 Organic Toddler Formul||10+
|Lebenswert Anfangsmilch Stage 2 organic follow-on milk||6+ months||1.43|
|HiPP UK Stage 1 Combiotic First Infant Milk||0-6
|HiPP UK Stage 2 combiotic follow-on milk for infants||6+ months||1.47|
|Kendamil Organic Step 1 First formula milk for infants||Since birth||1.10|
|Kendamil Organic Stage 2 Follow on Milk Formula||6+ months||1.06|
Below is an image of the recalled product labelled as infant formula
NAFDAC implores importers, distributors, retailers and consumers who have these products in storage to stop distribution, sale and use of these recalled products listed above.
NAFDAC encourages consumers and health care professionals to report adverse events related to the use of these recalled products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or via email@example.com or NAFDAC Med Safety Mobile App.