FDA MedWatch – Products Labeled as Infant Formula by Able Groupe:

TOPIC: Products Labeled as Infant Formula by Able Groupe: Recall – Formulas Have Insufficient Iron Levels and Products Do Not Meet Other FDA Requirements

AUDIENCE: Consumer, Health Professional

ISSUE: The recalled products are infant formulas 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.

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.

For more information about this recall, click on the red button “Read Recall” below.

BACKGROUND: The recalled products are intended as a complete or partial substitute for human milk for children 12 months old and younger. Inadequate intake of iron during infancy may lead to iron deficiency anemia, which, if untreated, has irreversible cognitive and functional development outcomes. 

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

Consumers and health professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.