The Recall Desk
SevereFDA (Food)·F-0914-2021·Announced 2021-08-25

HiPP German Stage 1 Infant Formula Lacks FDA Pre-Market Notification

Able Groupe Inc is recalling HiPP German Stage 1 Combiotic Infant Milk Formula because required FDA pre-market notifications were not submitted. Some units contain inadequate iron levels and lack required 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 is an FDA Class I recall for an infant formula with documented deficiencies: inadequate iron levels in some units that could harm vulnerable infants (premature, low birth weight, or those at risk for iron deficiency), combined with missing required FDA pre-market notification and non-compliant labeling. Class I infant formula recalls are inherently high-risk due to the vulnerable population and potential for nutritional harm.

Plain-English summary

Able Groupe Inc is recalling HiPP German Stage 1 Combiotic Infant Milk Formula (76,000 units total) because the required pre-market notifications for these infant formulas were not submitted to the FDA.

Some of the recalled products contain less than 1 milligram of iron per 100 Calories and 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 lack required labeling as mandated by 21 CFR 107.10 and 107.20 and do not bear mandatory labeling statements in English.

The products were sold directly through the firm's website (littlebundle.com). All lot codes are affected by this recall. Consumers who have purchased this product should contact Able Groupe Inc or consult their healthcare provider for guidance.

The recalled product

Product
HiPP German Stage 1 Combiotic Infant Milk Formula
Manufacturer
Able Groupe Inc
Category
Food — Infant Formula
Hazard
  • inadequate-iron
  • unlabeled-formula
  • missing-fda-notification

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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