FDA recall F-0909-2021

Able Groupe Inc · Class I · food

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.

Distribution

All sales are direct from firm website - littlebundle.com

Key facts

Status
Terminated
Initiation date
2021-08-08
Report date
2021-08-25
Termination date
2021-09-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sparks, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-0909-2021