Sparks, NV, United States
Able Groupe Inc recalls
1 recall recorded since 2018, most recently on 8 August 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1
Terminated Class I, Class II Food
- Recall started
- 8 August 2021
- Terminated
- 8 September 2021
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- F-0921-2021, F-0912-2021, F-0919-2021, F-0907-2021, F-0910-2021, F-0911-2021, F-0923-2021, F-0918-2021, F-0927-2021, F-0920-2021, F-0913-2021, F-0916-2021 and 9 more
- Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula
- HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula
- Holle Goat Stage 1 Organic Infant Milk Formula
- HiPP Comfort Milk Formula
- HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula
- HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula
- Lebenswert Folgemilch Stage 3 Organic Toddler Formula
- Holle Bio Stage 2 Organic Follow-On Infant Milk Formula
- and 13 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.