The Recall Desk
SevereFDA (Food)·F-0909-2021·Announced 2021-08-25

HiPP Dutch Stage 1 Infant Formula Recalled for Inadequate Iron Content

Able Groupe Inc is recalling HiPP Dutch Stage 1 Combiotic Infant Milk Formula because it was not approved by the FDA and may contain insufficient iron for vulnerable infants, particularly those born prematurely or 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 FDA classified this as a Class I recall, which per the rubric requires a minimum score of 4. The hazard—inadequate iron in infant formula—poses risk of serious health consequences including iron deficiency in vulnerable populations (premature infants, low-birth-weight infants), warranting the Severe classification.

Plain-English summary

Able Groupe Inc is recalling approximately 76,000 units of HiPP Dutch Stage 1 Combiotic Infant Milk Formula. The recall was initiated because the required pre-market notifications to the FDA were not submitted for these infant formulas.

The recalled formula may 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, infants with low iron levels at birth, and those at risk for iron deficiency due to illness.

Additionally, the products are not labeled in compliance with FDA regulations 21 CFR 107.10 and 107.20. The formula does not bear the required mandatory labeling statements in English.

All sales of the affected product were made directly through the firm's website at littlebundle.com. Consumers who have purchased this formula should consult with their healthcare provider about appropriate feeding options.

The recalled product

Product
HiPP Dutch Stage 1 Combiotic Infant Milk Formula
Manufacturer
Able Groupe Inc
Category
Food — Infant Formula
Hazard
  • inadequate-iron
  • unapproved-product
  • misbranding

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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