The Recall Desk
SevereFDA (Food)·F-0921-2021·Announced 2021-08-25

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
Hazard
  • inadequate-iron
  • mis-labeling
  • regulatory-violation

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.

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