Lebenswert Anfangsmilch Stage 1 Infant Formula Recall for Inadequate Iron and Labeling
Able Groupe Inc is recalling Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula because some products contain insufficient iron and lack required FDA labeling. The formula may not provide adequate iron for certain infants, including premature infants and those with low birth weight.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text states the FDA classification is Class I, which per the rubric requires a minimum score of 4. Additionally, the hazard involves inadequate iron in infant formula for vulnerable populations (premature infants, low birth weight infants) who are at risk for iron deficiency, representing a serious potential health impact to a high-risk population.
Plain-English summary
Able Groupe Inc is recalling all codes of Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula distributed through littlebundle.com. The recall affects approximately 76,000 units.
The recall was initiated because required pre-market notifications were not submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories, which may not provide adequate iron for certain infants. Infants at particular risk include those born prematurely, those with low birth weight, those with low iron levels at birth, or those at risk for iron deficiency due to illness.
All products are not labeled as required by FDA regulations 21 CFR 107.10 and 107.20 and do not bear mandatory labeling statements in English.
Consumers who have purchased this product should not feed it to infants and should consult with their healthcare provider.
The recalled product
- Product
- Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula
- Manufacturer
- Able Groupe Inc
- Category
- Food — Infant Formula
- Affected units
- 76,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All codes
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 21 recalled by Able Groupe Inc under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 21 products in this recall →Related recalls
Same manufacturer · Able Groupe Inc
See all →- SevereHiPP UK Stage 1 Infant Milk Formula Lacks Required FDA Approval
FDA (Food) · 2021-08-25
- HighKendamil Organic Stage 2 Infant Formula Recalled for Missing Labeling
FDA (Food) · 2021-08-25
- HighHolle Goat Stage 1 Organic Infant Milk Formula Recalled for Labeling Violations
FDA (Food) · 2021-08-25
- SevereHiPP Comfort Milk Formula Recalled for Inadequate Iron and Labeling Violations
FDA (Food) · 2021-08-25
- SevereHiPP Dutch Stage 2 Infant Formula Missing Pre-Market Approval and Labeling
FDA (Food) · 2021-08-25
Same hazard · inadequate iron
See all →- SevereHolle Bio Stage 1 Organic Infant Formula Recall for Inadequate Iron Content and Labeling
FDA (Food) · 2021-08-25
- SevereHiPP German Stage 1 Infant Formula Lacks FDA Pre-Market Notification
FDA (Food) · 2021-08-25
- SevereHiPP HA Infant Formula Recalled for Inadequate Iron and Missing Labeling
FDA (Food) · 2021-08-25
- SevereHiPP Dutch Stage 1 Infant Formula Recalled for Inadequate Iron Content
FDA (Food) · 2021-08-25