The Recall Desk
ModerateFDA (Food)·F-0913-2021·Announced 2021-08-25

HiPP HA Infant Formula Recalled for Missing FDA Premarket Notification and Labeling

Able Groupe Inc is recalling HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-On Infant Milk Formula because required FDA premarket notifications were not submitted and products lack mandatory English labeling as required by federal regulations.

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 involving labeling violations and failure to submit premarket notifications for infant formula. While labeling and notification failures are regulatory violations, the source text does not report any illnesses, injuries, or adverse health events, making this a precautionary regulatory enforcement action rather than a hazard-based safety recall.

Plain-English summary

Able Groupe Inc is recalling HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-On Infant Milk Formula, totaling 76,000 units. The recall was initiated because the required premarket notifications for these infant formulas have not been submitted to the FDA, and the products are not labeled as required by 21 CFR 107.10 and 107.20. Additionally, the products do not bear mandatory labeling statements in English.

The product has been distributed exclusively through direct sales from the firm's website at littlebundle.com. All product codes are affected by this recall.

Consumers who have purchased this product should not use it. Parents and caregivers should contact the firm or consult with a healthcare provider regarding feeding alternatives for their infants.

The recalled product

Product
HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-On Infant Milk Formula
Manufacturer
Able Groupe Inc
Category
Food — Infant Formula
Hazard
  • labeling-violation
  • premarket-notification-missing

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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