The Recall Desk
SevereFDA (Food)·F-0910-2021·Announced 2021-08-25

HiPP HA Infant Formula Recalled for Inadequate Iron and Missing Labeling

Able Groupe Inc is recalling HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula (76,000 units) because some products contain less than the required iron per serving and lack mandatory FDA-compliant English labeling.

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: This recall is FDA Class I, which per the rubric requires a minimum score of 4. The hazard—inadequate iron in infant formula—poses significant risk to vulnerable populations (premature infants, low birth weight infants) who depend entirely on formula for nutrition.

Plain-English summary

Able Groupe Inc is recalling HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula because the products were not submitted for required FDA pre-market notification and do not meet FDA standards.

Some units contain less than 1 milligram of iron per 100 Calories, which may not provide adequate iron for some 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 recalled 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. The recalled products (all codes) were sold directly through the firm's website at littlebundle.com. A total of 76,000 units are affected.

Consumers who have purchased this product should not use it and should contact Able Groupe Inc directly for information about returns or replacement.

The recalled product

Product
HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula
Manufacturer
Able Groupe Inc
Category
Food — Infant Formula
Hazard
  • inadequate-iron
  • missing-labeling
  • labeling-non-compliance

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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