The Recall Desk
SevereFDA (Food)·F-0907-2021·Announced 2021-08-25

HiPP Comfort Milk Formula Recalled for Inadequate Iron and Labeling Violations

Able Groupe Inc is recalling HiPP Comfort Milk Formula because some products contain insufficient iron and lack required labeling. The formula may not provide adequate iron for certain infants, particularly premature or low-birth-weight infants.

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 FDA classified this as a Class I recall. The hazard—inadequate iron in infant formula—directly affects a vulnerable population (infants, particularly premature and low-birth-weight infants) at risk for serious developmental and health consequences from iron deficiency. Although no illnesses are reported in the source text, Class I classification mandates a minimum score of 4 per the rubric.

Plain-English summary

Able Groupe Inc is recalling all codes of HiPP Comfort Milk Formula sold directly through littlebundle.com. The recall involves approximately 76,000 units total.

The products were distributed without required pre-market notifications to the FDA. Some products contain less than 1 milligram of iron per 100 Calories, which may not provide adequate iron for certain infants, particularly those born prematurely, with low birth weight, with low iron levels at birth, or at risk for iron deficiency due to illness.

Additionally, 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.

Consumers who have purchased this formula should stop use and may contact Able Groupe Inc through littlebundle.com for further instructions.

The recalled product

Product
HiPP Comfort Milk Formula
Manufacturer
Able Groupe Inc
Category
Food — Infant Formula
Hazard
  • inadequate-iron
  • mis-labeling
  • unlabeled-product

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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