Able Groupe recalling infant formula due to products not meeting FDA standards

Product Recalls

Able Groupe infant formulas (FDA images)

The FDA has released the following:

Able Groupe announced today it is recalling certain products used as infant formulas.

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. In addition, the 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 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. 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. These 8 infant formula product labels do not include the required statement. Furthermore, all of the infant formulas distributed by Able Group are not labeled as required by 21 CFR 107.10 and 107.20 and do not bear mandatory labeling statements in English.

The products were imported from Europe and distributed to consumers in the U.S. via mail services. The products were purchased through the littlebundle website (www.littlebundle.com). The products were not available at any retail store. The company began distributing the products on May 20, 2021. Approximately 76,000 units were distributed.

The company identified the products as follows: (iron levels provided after each product name, milligrams per 100 Calories) All lots codes are being recalled.

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 who have these products at home should not use them as infant formula and should safely dispose of them immediately.

Click here for additional product images.

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

Copyright 2021 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

Business News

More Business News

Political News

More Political News

Technology News

More Technology News

Science News

More Science News

Entertainment News

More Entertainment News

Odd News

More Odd News

Popular