Baby formula recalled for not meeting FDA standards, not having enough iron

National

(AP Photo/Denis Farrell)

(WKBN) – Able Groupe is recalling some infant formula for not meeting Food and Drug Administration standards.

The recall, announced Monday, is for certain products labeled infant formula that were sold under the brand names HiPP, Holle, Bioland and Kendamil. The recall is being coordinated with the FDA.

(Credit: FDA)

The FDA says the formula contains insufficient amounts of iron and also fails to meet other FDA requirements. If babies do not get enough iron, it could lead to iron deficiency anemia, “which, if untreated, has irreversible cognitive and functional development outcomes,” the FDA said.

The products contain less than 1 milligram of iron per 100 calories, an insufficiency that particularly affects infants born prematurely or with low birth weight, those born with low iron levels, or babies at risk for becoming iron deficient because of illness.

Infant formula products that contain insufficient amounts of iron are required to state on the label that more iron may be necessary. The labels for the eight recalled infant formula products do not include that statement.

The affected formula was purchased through the LittleBundle website. It was imported from Europe and mailed to customers. It was not sold at any retail store.

The company began shipping the products on May 20, 2021, and says approximately 76,000 units were distributed.

The following products are affected by the recall:

ProductAgeIron mg per 100 Calories
HiPP Anti-Reflux Milk FormulaFrom birth1.06
HiPP Comfort Milk FormulaFrom birth0.91
HiPP Dutch Stage 1 Combiotic Infant Milk Formula0-6
months
0.76
HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula6+ months1.47
HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula0-6
months
0.76
HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula6+ months1.01
HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-on Milk Formula6+ months1.43
HiPP German Stage 1 Combiotic Infant Milk Formula0-6
months
0.90
HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula6+ months1.47
Holle Bio Stage PRE Organic Infant Milk Formula0-6
months
0.81
Holle Bio Stage 1 Organic Infant Milk Formula0-6
months
0.81
Holle Bio Stage 2 Organic Follow-on Milk Formula6+ months1.18
Holle Goat Stage 1 Organic Infant Milk Formula0-6
months
0.99
Holle Goat Stage 2 Organic Follow-On Infant Milk Formula6+ months1.47
Holle Goat Stage 3 Organic Toddler Formula10+
months
1.52
Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula0-6
months
0.88
Lebenswert Anfangsmilch Stage 2 Organic Follow-on Milk Formula6+ months1.43
HiPP UK Stage 1 Combiotic First Infant Milk Formula0-6
months
0.76
HiPP UK Stage 2 Combiotic Follow-on Infant Milk Formula6+ months1.47
Kendamil Organic Stage 1 First Infant Milk FormulaFrom birth1.10
Kendamil Organic Stage 2 Follow on Milk Formula6+ months1.06

Consumers should not use the recalled products, but rather dispose of them. Customers with questions are instructed to email recallquestions@ablegroupe.com.

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