HIGH RISK Terminated F-0909-2021

HiPP Dutch Stage 1 Combiotic Infant Milk Formula

Recalled by Able Groupe Inc

Classification

Class I — Dangerous or defective products that predictably could cause serious health problems or death.

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.

Product Details

Product Quantity
76,000 units total
Product Type
Food
Code Info
All codes
Voluntary/Mandated
Voluntary: Firm initiated

Distribution & Geography

Distribution Pattern
All sales are direct from firm website - littlebundle.com
Company Location
Sparks, NV, 89431-6428

Timeline

Report Date
08/25/2021
Recall Initiated
08/08/2021
Classification Date
09/01/2021
Termination Date
09/08/2021

Source: U.S. Food & Drug Administration (FDA) — FDA Recalls

Last updated: August 28, 2026

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