Able Groupe Inc

Recall #F-0909-2021 · Initiated 2021-08-08

Product

HiPP Dutch Stage 1 Combiotic Infant Milk Formula

Reason for recall

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some 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, had low iron levels at birth, or are at risk for becoming iron deficient due to illness. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

Quantity affected

76,000 units total

Distribution

All sales are direct from firm website - littlebundle.com

Lot / code info

All codes

Voluntary / mandated

Voluntary: Firm initiated

Initial notification

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Terminated

2021-09-08