The Recall Desk
ModerateFDA (Food)·F-0912-2021·Announced 2021-08-25

HiPP HA Infant Formula Recalled for Missing Pre-Market Notification

Able Groupe Inc is recalling HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula because required pre-market notifications were not submitted to the FDA and products lack mandatory English labeling.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall. The source text does not report any illnesses, injuries, or deaths. The hazard is non-compliance with pre-market notification and labeling requirements rather than a confirmed product defect or contamination. No actual harm has been reported.

Plain-English summary

Able Groupe Inc is recalling approximately 76,000 units of HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula sold directly through littlebundle.com.

The recall was issued because required pre-market notifications for these new infant formulas were not submitted to the FDA. Additionally, all products are not labeled as required by 21 CFR 107.10 and 107.20 and do not bear mandatory labeling statements in English.

Consumers who have purchased this product should not use it and should contact the firm for further instructions. Infant formulas sold in the United States must comply with FDA pre-market notification requirements and labeling standards.

The recalled product

Product
HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula
Manufacturer
Able Groupe Inc
Category
Food — Infant Formula
Hazard
  • mis-labeling
  • regulatory-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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