Able Groupe Inc recalls Holle Bio Stage PRE Organic Infant Milk Formula

Recall date

August 8, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

F-0917-2021

FDA classification

Class I

Brand / firm

Able Groupe Inc

Sold / distributed

All sales are direct from firm website - littlebundle.com

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Holle Bio Stage PRE Organic Infant Milk Formula