Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula

FDA recall notice · announced August 25, 2021 · Able Groupe

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

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.

Notes

Distribution: All sales are direct from firm website - littlebundle.com
Lot/code information: All codes
Quantity: 76,000 units total
Status: Terminated
Products in this recall event:
- HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula (F-0912-2021)
- Holle Goat Stage 1 Organic Infant Milk Formula (F-0919-2021)
- HiPP Comfort Milk Formula (F-0907-2021)
- HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula (F-0910-2021)
- HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula (F-0911-2021)
- Lebenswert Folgemilch Stage 3 Organic Toddler Formula (F-0923-2021)
- Holle Bio Stage 2 Organic Follow-On Infant Milk Formula (F-0918-2021)
- Kendamil Organic Stage 2 Follow on Milk Formula (F-0927-2021)
- Holle Goat Stage 2 Organic Follow-On Infant Milk Formula (F-0920-2021)
- HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-On Infant Milk Formula (F-0913-2021)
- Holle Bio Stage 1 Organic Infant Milk Formula (F-0916-2021)
- HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula (F-0925-2021)
- Holle Bio Stage PRE Organic Infant Milk Formula (F-0917-2021)
- HiPP German Stage 1 Combiotic Infant Milk Formula (F-0914-2021)
- Lebenswert Folgemilch Stage 2 Organic Follow-On Infant Milk Formula (F-0922-2021)
- HiPP AR Germany Anti-Reflux Milk Formula (F-0908-2021)
- HiPP UK Stage 1 Combiotic First Infant Milk Formula (F-0924-2021)
- Kendamil Organic Stage 1 First Infant Milk Formula (F-0926-2021)
- HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula (F-0915-2021)
- HiPP Dutch Stage 1 Combiotic Infant Milk Formula (F-0909-2021)
- Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula (F-0921-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.