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

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(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 was 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.


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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:

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

Consumers should not use the recalled products. Instead, they should throw them out. If you have questions, you can email recallquestions@ablegroupe.com.

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