# FDA recall F-0907-2021

> **Able Groupe Inc** · Class I · food recall initiated 2021-08-08.

## Product

HiPP Comfort 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

- **Recall number:** F-0907-2021
- **Recalling firm:** Able Groupe Inc
- **Classification:** Class I
- **Product type:** food
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-0907-2021

## Citation

> AI Analytics. FDA recall F-0907-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/F-0907-2021. Source: US FDA. Licensed CC0.

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